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Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00078559
Recruitment Status : Completed
First Posted : March 2, 2004
Results First Posted : July 9, 2012
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Kidney Transplantation
Kidney Disease
Interventions Drug: Alemtuzumab
Drug: Sirolimus
Drug: Tacrolimus
Procedure: Kidney transplant
Drug: Methylprednisolone (or equivalent)
Drug: Acetaminophen
Drug: Diphenhydramine
Drug: Trimethoprim (TMP)/Sulfa (Bactrim, Septra)
Drug: Valgancyclovir
Drug: Acyclovir
Drug: Pentamidine
Drug: Clotrimazole
Drug: Nystatin
Enrollment 10
Recruitment Details For this trial, one center in the United States enrolled ten eligible adult recipients of first kidney transplants (0-3 human leukocyte antigen (HLA)-antigen mismatch) from February 2005 to February 2006
Pre-assignment Details At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form. Refer to inclusion and exclusion criteria section for more details
Arm/Group Title Alemtuzumab
Hide Arm/Group Description Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Period Title: Overall Study
Started 10
Completed 10 [1]
Not Completed 0
[1]
1 subject stopped study drug due to a severe but non-serious AE, and completed the trial
Arm/Group Title Alemtuzumab
Hide Arm/Group Description Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
45.3  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Primary Cause of Renal Failure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
Glomerulonephritis 0
Pyelonephritis/Interstitial Nephritis 0
Cystic/Polycystic Kidney Disease 4
Hypertension 0
Diabetes Mellitus 1
Obstructive/Reflux Nephropathy 1
IgA Nephropathy 2
Post-streptococcal Glomerular Nephritis 0
Systemic Lupus Erythematosus 0
Etiology Uncertain 2
Other 0
Pre-Transplant Dialysis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
Hemodialysis and Peritoneal Dialysis 0
Hemodialysis 5
Peritoneal Dialysis 0
Dialysis - Unknown Type 0
Participants without pre-transplant dialysis 5
[1]
Measure Description: Whether or not participant received dialysis pre-transplant and if they did, the type they received.
1.Primary Outcome
Title Number of Acute Rejections in All Enrolled Participants
Hide Description

Number of acute rejections[1] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant)

  1. Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Time Frame Four years post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Rejection Events
1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alemtuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% Confidence Interval
Comments Exact Binomial
Method of Estimation Estimation Parameter Proportion with acute rejection
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
0.01 to 0.34
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal
Hide Description

Following sirolimus withdrawal, the number of acute rejections[1] in all enrolled participants

1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.

[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Time Frame Transplantation to end of study (up to four years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Rejection Events
0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alemtuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% Confidence Interval
Comments Exact Binomial
Method of Estimation Estimation Parameter Proportion with acute rejection
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0 to 0.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study
Hide Description

Acute rejections[1] between initiation of sirolimus withdrawal and end of study

1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.

[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Time Frame Initiation of sirolimus to end of study (up to four years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Sirolimus withdrawal initiation participant sample
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Rejection Events
0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alemtuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% Confidence Interval
Comments Exact Binomial
Method of Estimation Estimation Parameter Proportion with acute rejection
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0 to 0.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated
Hide Description

Time (days) to acute rejection[1] for participants where sirolimus was not initiated

1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.

[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Time Frame Transplantation to acute rejection (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for whom sirolimus withdrawal was not initiated
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Days
274
5.Secondary Outcome
Title Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period
Hide Description

Time (days) to acute rejection[1] for participants occurring during the year following transplantation

1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.

[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Time Frame Transplantation to acute rejection (up to one year post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with acute rejections for whom sirolimus withdrawal was not initiated
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Days
274
6.Secondary Outcome
Title Number of Deaths Stratified by Sirolimus Withdrawal Status
Hide Description Participants who died during the study, all cause(s)
Time Frame Transplantation to Death (up to four years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab (Withdrawn From Sirolimus) Alemtuzumab (Not Withdrawn From Sirolimus)
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
Overall Number of Participants Analyzed 2 8
Measure Type: Number
Unit of Measure: deaths
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alemtuzumab (Withdrawn From Sirolimus), Alemtuzumab (Not Withdrawn From Sirolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% Confidence Interval
Comments Exact Binomial
Method of Estimation Estimation Parameter Exact Binomial
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0 to 0.3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status
Hide Description

Participants who experienced graft loss[1] during study

[1]Graft loss is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation

Time Frame Transplantation to Graft Loss (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab (Withdrawn From Sirolimus) Alemtuzumab (Not Withdrawn From Sirolimus)
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
Overall Number of Participants Analyzed 2 8
Measure Type: Number
Unit of Measure: participants
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alemtuzumab (Withdrawn From Sirolimus), Alemtuzumab (Not Withdrawn From Sirolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% Confidence Interval
Comments Exact Binomial for all participants (n=10)
Method of Estimation Estimation Parameter Exact Binomial
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0 to 0.3
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status
Hide Description

Participants who experienced severe acute rejections[1] during study

  1. Severe acute rejection is defined as that which requires treatment with anti-lymphocyte antibody or is histologically evaluated as Type IIA or greater using the Banff 1997 criteria[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Time Frame Transplantation to severe acute rejection (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab (Withdrawn From Sirolimus) Alemtuzumab (Not Withdrawn From Sirolimus)
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
Overall Number of Participants Analyzed 2 8
Measure Type: Number
Unit of Measure: Rejection Events
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alemtuzumab (Withdrawn From Sirolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% Confidence Interval
Comments Exact Binomial for Not Withdrawn Group
Method of Estimation Estimation Parameter Exact Binomial
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0 to 0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alemtuzumab (Not Withdrawn From Sirolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% Confidence Interval
Comments Exact Binomial for Withdrawn Group
Method of Estimation Estimation Parameter Exact Binomial
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0 to 0.8
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status
Hide Description

Participants who experienced acute rejection[1] during study which required anti-lymphocyte (OKT3, ATG) therapy

1] Acute rejection is defined as a biopsy-prove rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.

[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Time Frame Transplantation to acute rejection (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab (Withdrawn From Sirolimus) Alemtuzumab (Not Withdrawn From Sirolimus)
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
Overall Number of Participants Analyzed 2 8
Measure Type: Number
Unit of Measure: participants
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alemtuzumab (Withdrawn From Sirolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% Confidence Interval
Comments Exact Binomial for Not Withdrawn Group
Method of Estimation Estimation Parameter Exact Binomial
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0 to 0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alemtuzumab (Not Withdrawn From Sirolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% Confidence Interval
Comments Exact Binomial for Withdrawn Group
Method of Estimation Estimation Parameter Exact Binomial
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0 to 0.8
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
Hide Description [Not Specified]
Time Frame Transplantation to end of study (up to four years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab (Withdrawn From Sirolimus) Alemtuzumab (Not Withdrawn From Sirolimus)
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
Overall Number of Participants Analyzed 2 8
Measure Type: Number
Unit of Measure: adverse events
2 8
11.Secondary Outcome
Title Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
Hide Description [Not Specified]
Time Frame Transplantation to end of study (up to four years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab (Withdrawn From Sirolimus) Alemtuzumab (Not Withdrawn From Sirolimus)
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
Overall Number of Participants Analyzed 2 8
Measure Type: Number
Unit of Measure: adverse events
0 2
12.Secondary Outcome
Title Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
Hide Description [Not Specified]
Time Frame Transplantation to end of study (up to four years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab (Withdrawn From Sirolimus) Alemtuzumab (Not Withdrawn From Sirolimus)
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
Overall Number of Participants Analyzed 2 8
Measure Type: Number
Unit of Measure: adverse events
2 7
13.Secondary Outcome
Title Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status
Hide Description Side effects of conventional immunosuppression include increased body weight and hypertension
Time Frame Transplantation to end of study (up to four years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab (Withdrawn From Sirolimus) Alemtuzumab (Not Withdrawn From Sirolimus)
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
Overall Number of Participants Analyzed 2 8
Measure Type: Number
Unit of Measure: side effects
2 6
14.Secondary Outcome
Title Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status
Hide Description Mean change from transplantation to Month 48 in serum creatinine. Normal serum creatinine range is from 0.7 – 1.4 mg/dL. In a transplant population, starting serum creatinine is higher than normal range. A negative change indicates better renal function
Time Frame Transplantation to end of study (up to four years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab (Withdrawn From Sirolimus) Alemtuzumab (Not Withdrawn From Sirolimus)
Hide Arm/Group Description:
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
Overall Number of Participants Analyzed 2 8
Mean (Standard Deviation)
Unit of Measure: mg/dL
-4.2  (2.3) -5.4  (2.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alemtuzumab
Hide Arm/Group Description Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
All-Cause Mortality
Alemtuzumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alemtuzumab
Affected / at Risk (%) # Events
Total   5/10 (50.00%)    
Blood and lymphatic system disorders   
Anaemia  1  1/10 (10.00%)  1
Gastrointestinal disorders   
Ileus  1  1/10 (10.00%)  1
Immune system disorders   
Transplant rejection  1  1/10 (10.00%)  1
Infections and infestations   
Escherichia sepsis  1  1/10 (10.00%)  1
Gas gangrene  1  1/10 (10.00%)  1
Pneumonia klebsiella  1  1/10 (10.00%)  1
Injury, poisoning and procedural complications   
Incisional hernia  1  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Osteonecrosis  1  1/10 (10.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Renal cell carcinoma  1  1/10 (10.00%)  1
Nervous system disorders   
Syncope  1  1/10 (10.00%)  1
Renal and urinary disorders   
Proteinuria  1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/10 (10.00%)  1
Vascular disorders   
Deep vein thrombosis  1  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alemtuzumab
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  8/10 (80.00%)  17
Leukocytosis  1  2/10 (20.00%)  2
Leukopenia  1  8/10 (80.00%)  14
Lymphadenitis  1  1/10 (10.00%)  1
Lymphadenopathy  1  1/10 (10.00%)  1
Lymphopenia  1  10/10 (100.00%)  10
Neutropenia  1  3/10 (30.00%)  4
Thrombocytopenia  1  3/10 (30.00%)  3
Cardiac disorders   
Atrial fibrillation  1  1/10 (10.00%)  2
Pericardial effusion  1  1/10 (10.00%)  1
Sinus tachycardia  1  5/10 (50.00%)  6
Supraventricular extrasystoles  1  1/10 (10.00%)  1
Tachycardia  1  1/10 (10.00%)  1
Ventricular extrasystoles  1  1/10 (10.00%)  1
Endocrine disorders   
Cushingoid  1  1/10 (10.00%)  1
Hyperparathyroidism  1  1/10 (10.00%)  1
Hyperparathyroidism secondary  1  1/10 (10.00%)  1
Hyperthyroidism  1  1/10 (10.00%)  3
Eye disorders   
Abnormal sensation in eye  1  1/10 (10.00%)  1
Blepharospasm  1  1/10 (10.00%)  1
Cataract  1  1/10 (10.00%)  1
Conjunctivitis  1  1/10 (10.00%)  1
Eyelid oedema  1  1/10 (10.00%)  1
Vision blurred  1  2/10 (20.00%)  2
Visual acuity reduced  1  2/10 (20.00%)  2
Gastrointestinal disorders   
Abdominal discomfort  1  1/10 (10.00%)  1
Abdominal distension  1  6/10 (60.00%)  6
Abdominal hernia  1  1/10 (10.00%)  1
Abdominal pain  1  3/10 (30.00%)  3
Abdominal pain lower  1  1/10 (10.00%)  1
Aphthous stomatitis  1  2/10 (20.00%)  2
Constipation  1  5/10 (50.00%)  7
Diarrhoea  1  6/10 (60.00%)  14
Dry mouth  1  1/10 (10.00%)  1
Eructation  1  1/10 (10.00%)  1
Flatulence  1  2/10 (20.00%)  2
Gastrointestinal sounds abnormal  1  7/10 (70.00%)  7
Gastrooesophageal reflux disease  1  2/10 (20.00%)  2
Glossodynia  1  1/10 (10.00%)  1
Ileus  1  2/10 (20.00%)  2
Localised intraabdominal fluid collection  1  1/10 (10.00%)  1
Mouth ulceration  1  2/10 (20.00%)  2
Nausea  1  6/10 (60.00%)  10
Sensitivity of teeth  1  1/10 (10.00%)  1
Stomatitis  1  1/10 (10.00%)  1
Toothache  1  2/10 (20.00%)  2
Vomiting  1  3/10 (30.00%)  5
General disorders   
Chills  1  1/10 (10.00%)  1
Fatigue  1  5/10 (50.00%)  7
Gait disturbance  1  1/10 (10.00%)  1
Generalised oedema  1  5/10 (50.00%)  6
Infusion site extravasation  1  1/10 (10.00%)  1
Malaise  1  2/10 (20.00%)  2
Oedema  1  2/10 (20.00%)  2
Oedema peripheral  1  9/10 (90.00%)  19
Pain  1  1/10 (10.00%)  1
Pyrexia  1  6/10 (60.00%)  11
Xerosis  1  1/10 (10.00%)  1
Hepatobiliary disorders   
Gallbladder polyp  1  1/10 (10.00%)  1
Hepatic cyst  1  1/10 (10.00%)  1
Immune system disorders   
Hypersensitivity  1  1/10 (10.00%)  1
Seasonal allergy  1  3/10 (30.00%)  5
Infections and infestations   
Bronchitis  1  1/10 (10.00%)  1
Cellulitis  1  2/10 (20.00%)  2
Chromoblastomycosis  1  1/10 (10.00%)  1
Cytomegalovirus viraemia  1  2/10 (20.00%)  2
Escherichia urinary tract infection  1  1/10 (10.00%)  1
Eyelid folliculitis  1  1/10 (10.00%)  1
Folliculitis  1  1/10 (10.00%)  2
Gastroenteritis viral  1  3/10 (30.00%)  5
Herpes zoster  1  1/10 (10.00%)  1
Human polyomavirus infection  1  1/10 (10.00%)  1
Incision site cellulitis  1  1/10 (10.00%)  1
Influenza  1  1/10 (10.00%)  1
Klebsiella infection  1  2/10 (20.00%)  3
Nasopharyngitis  1  1/10 (10.00%)  1
Oral candidiasis  1  1/10 (10.00%)  1
Oral herpes  1  1/10 (10.00%)  1
Pharyngitis  1  1/10 (10.00%)  1
Pneumonia cryptococcal  1  1/10 (10.00%)  1
Sinusitis  1  4/10 (40.00%)  9
Upper respiratory tract infection  1  5/10 (50.00%)  8
Urinary tract infection  1  2/10 (20.00%)  4
Urinary tract infection bacterial  1  2/10 (20.00%)  3
Urinary tract infection staphylococcal  1  1/10 (10.00%)  2
Viral upper respiratory tract infection  1  1/10 (10.00%)  1
Injury, poisoning and procedural complications   
Back injury  1  1/10 (10.00%)  1
Chronic allograft nephropathy  1  2/10 (20.00%)  2
Complications of transplanted kidney  1  1/10 (10.00%)  1
Contusion  1  3/10 (30.00%)  3
Dialysis device complication  1  1/10 (10.00%)  1
Drug toxicity  1  1/10 (10.00%)  1
Excoriation  1  1/10 (10.00%)  1
Fall  1  1/10 (10.00%)  1
Incision site complication  1  10/10 (100.00%)  12
Incision site pain  1  10/10 (100.00%)  12
Incisional hernia  1  1/10 (10.00%)  1
Incorrect dose administered  1  1/10 (10.00%)  1
Open wound  1  1/10 (10.00%)  1
Perinephric collection  1  1/10 (10.00%)  1
Post procedural haematoma  1  1/10 (10.00%)  1
Renal injury  1  1/10 (10.00%)  1
Seroma  1  1/10 (10.00%)  1
Skin laceration  1  1/10 (10.00%)  1
Investigations   
Alanine aminotransferase increased  1  6/10 (60.00%)  6
Aspartate aminotransferase increased  1  3/10 (30.00%)  3
Blood alkaline phosphatase increased  1  5/10 (50.00%)  7
Blood creatinine increased  1  4/10 (40.00%)  6
Blood lactate dehydrogenase increased  1  6/10 (60.00%)  7
Breath sounds abnormal  1  10/10 (100.00%)  12
Gamma-glutamyltransferase increased  1  4/10 (40.00%)  6
Oxygen saturation decreased  1  1/10 (10.00%)  1
Urine output decreased  1  1/10 (10.00%)  1
Weight decreased  1  1/10 (10.00%)  1
Weight increased  1  6/10 (60.00%)  8
Metabolism and nutrition disorders   
Dehydration  1  4/10 (40.00%)  4
Dyslipidaemia  1  3/10 (30.00%)  3
Gout  1  1/10 (10.00%)  1
Hypercalcaemia  1  1/10 (10.00%)  1
Hyperglycaemia  1  3/10 (30.00%)  3
Hyperkalaemia  1  1/10 (10.00%)  1
Hyperlipidaemia  1  9/10 (90.00%)  11
Hypertriglyceridaemia  1  3/10 (30.00%)  3
Hypocalcaemia  1  1/10 (10.00%)  1
Hypokalaemia  1  2/10 (20.00%)  3
Hypomagnesaemia  1  3/10 (30.00%)  3
Hyponatraemia  1  2/10 (20.00%)  3
Hypophosphataemia  1  6/10 (60.00%)  7
Increased appetite  1  1/10 (10.00%)  1
Metabolic acidosis  1  2/10 (20.00%)  3
Obesity  1  2/10 (20.00%)  2
Vitamin D deficiency  1  3/10 (30.00%)  3
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/10 (30.00%)  4
Back pain  1  2/10 (20.00%)  2
Joint stiffness  1  1/10 (10.00%)  1
Muscle spasms  1  1/10 (10.00%)  1
Muscle twitching  1  1/10 (10.00%)  1
Muscular weakness  1  1/10 (10.00%)  1
Musculoskeletal chest pain  1  1/10 (10.00%)  1
Musculoskeletal pain  1  1/10 (10.00%)  1
Myalgia  1  5/10 (50.00%)  6
Neck pain  1  1/10 (10.00%)  1
Osteopenia  1  4/10 (40.00%)  4
Osteoporosis  1  1/10 (10.00%)  1
Pain in extremity  1  4/10 (40.00%)  6
Pain in jaw  1  1/10 (10.00%)  1
Plantar fasciitis  1  1/10 (10.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung neoplasm  1  1/10 (10.00%)  1
Nervous system disorders   
Burning sensation  1  1/10 (10.00%)  1
Dizziness  1  3/10 (30.00%)  3
Dysgeusia  1  1/10 (10.00%)  1
Headache  1  3/10 (30.00%)  6
Hypoaesthesia  1  1/10 (10.00%)  1
Neuropathy peripheral  1  3/10 (30.00%)  3
Restless legs syndrome  1  1/10 (10.00%)  1
Tremor  1  2/10 (20.00%)  2
Psychiatric disorders   
Agitation  1  1/10 (10.00%)  1
Disorientation  1  1/10 (10.00%)  1
Renal and urinary disorders   
Dysuria  1  1/10 (10.00%)  1
Haematuria  1  6/10 (60.00%)  6
Hydronephrosis  1  1/10 (10.00%)  1
Hydroureter  1  1/10 (10.00%)  1
Micturition urgency  1  1/10 (10.00%)  1
Nephropathy toxic  1  3/10 (30.00%)  3
Pollakiuria  1  1/10 (10.00%)  2
Proteinuria  1  4/10 (40.00%)  6
Pyelocaliectasis  1  2/10 (20.00%)  2
Renal infarct  1  1/10 (10.00%)  1
Ureteral disorder  1  1/10 (10.00%)  1
Urethral stenosis  1  1/10 (10.00%)  1
Urinary retention  1  1/10 (10.00%)  1
Reproductive system and breast disorders   
Ovarian cyst  1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Apnoea  1  1/10 (10.00%)  1
Atelectasis  1  1/10 (10.00%)  1
Cough  1  3/10 (30.00%)  4
Dyspnoea  1  4/10 (40.00%)  5
Dyspnoea exertional  1  2/10 (20.00%)  3
Epistaxis  1  1/10 (10.00%)  1
Nasal congestion  1  1/10 (10.00%)  1
Oropharyngeal pain  1  1/10 (10.00%)  1
Pleural effusion  1  1/10 (10.00%)  1
Productive cough  1  1/10 (10.00%)  1
Pulmonary congestion  1  1/10 (10.00%)  1
Pulmonary oedema  1  1/10 (10.00%)  1
Rhinorrhoea  1  1/10 (10.00%)  1
Wheezing  1  2/10 (20.00%)  2
Skin and subcutaneous tissue disorders   
Acne  1  2/10 (20.00%)  4
Actinic keratosis  1  1/10 (10.00%)  1
Blister  1  1/10 (10.00%)  1
Dermatitis  1  1/10 (10.00%)  1
Erythema  1  1/10 (10.00%)  1
Ingrown hair  1  1/10 (10.00%)  1
Nail discolouration  1  1/10 (10.00%)  1
Pain of skin  1  1/10 (10.00%)  1
Pruritus  1  10/10 (100.00%)  11
Rash  1  5/10 (50.00%)  5
Urticaria  1  6/10 (60.00%)  6
Vascular disorders   
Deep vein thrombosis  1  1/10 (10.00%)  1
Flushing  1  2/10 (20.00%)  2
Haematoma  1  1/10 (10.00%)  1
Hypertension  1  6/10 (60.00%)  10
Hypotension  1  4/10 (40.00%)  4
Lymphocele  1  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
The absence of a control group in this pilot trial precludes any comparison between alemtuzumab-induced patients with further minimization and patients with more conventional immunosuppressive approaches, and is a limitation of the current study
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arjang Djamali, MD, MS, FASN
Organization: University of Wisconsin - Department of Medicine, Madison, Wisconsin
Phone: 608-262-7330
EMail: axd@medicine.wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00078559     History of Changes
Obsolete Identifiers: NCT00585130
Other Study ID Numbers: DAIT ITN013ST
H-2003-0435 ( Other Identifier: HS IRB )
First Submitted: March 1, 2004
First Posted: March 2, 2004
Results First Submitted: April 13, 2012
Results First Posted: July 9, 2012
Last Update Posted: June 29, 2018