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A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf (Astellas)

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: NCT01265537
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Jagbir Gill, University of British Columbia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Graft Rejection
Diabetes
Intervention Drug: Tacrolimus
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Period Title: Overall Study
Started 15 15
Completed 13 13
Not Completed 2 2
Reason Not Completed
Adverse Event             2             1
Physician Decision             0             1
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf) Total
Hide Arm/Group Description

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
The discrepancy in the Baseline Analysis Population Description and the Overall Number of Baseline Participants is seen because 28 participants in total completed their baseline assessments.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
61.8
(49.2 to 66.6)
50.4
(46.6 to 56.5)
54.3
(47.1 to 62.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
4
  28.6%
4
  28.6%
8
  28.6%
Male
10
  71.4%
10
  71.4%
20
  71.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Asian
0
   0.0%
4
  28.6%
4
  14.3%
Caucasian/White
13
  92.9%
9
  64.3%
22
  78.6%
Other/Multiracial
1
   7.1%
0
   0.0%
1
   3.6%
Pacific Islander
0
   0.0%
1
   7.1%
1
   3.6%
Family History of Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
6 6 12
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 14 participants 14 participants 28 participants
25.1  (3.0) 27.5  (6.3) 26.4  (5.1)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 14 participants 14 participants 28 participants
150  (21) 159  (27) 154  (24)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 14 participants 14 participants 28 participants
81  (9) 87  (9) 84  (9)
Cholesterol Medications  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Yes
4
  28.6%
2
  14.3%
6
  21.4%
No
10
  71.4%
12
  85.7%
22
  78.6%
Cholestoral  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 14 participants 14 participants 28 participants
4.56  (0.97) 4.43  (0.60) 4.49  (0.78)
Low-Density Lipoproteins  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 14 participants 14 participants 28 participants
2.72  (0.82) 2.68  (0.76) 2.70  (0.77)
High-Density Lipoproteins  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 14 participants 14 participants 28 participants
1.21  (0.28) 1.37  (0.62) 1.30  (0.49)
Triglycerides  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 14 participants 14 participants 28 participants
1.38  (0.36) 1.52  (1.08) 1.46  (0.82)
Fasting Glucose  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 14 participants 14 participants 28 participants
5.6  (0.8) 5.2  (0.6) 5.4  (0.7)
Random Glucose  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 14 participants 14 participants 28 participants
5.5  (1.3) 5.7  (1.1) 5.6  (1.2)
Peak Panel-Reactive Antibody (PRA) before transplant   [1] 
Median (Full Range)
Unit of measure:  %
Number Analyzed 14 participants 14 participants 28 participants
0
(0 to 9)
0
(0 to 6)
0
(0 to 9)
[1]
Measure Description: Panel reactive antibody (PRA) testing is performed on patients prior to transplantation in an effort to identify the potential presence of anti-HLA antibodies and minimize the risk of antibody mediated rejection. The inclusion criteria for this study was a peak PRA <10%.
Donor Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Living 11 3 14
Deceased 3 11 14
Donor Age  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
41
(33 to 53)
34
(26 to 56)
39
(31 to 54)
Human Leukocyte Antigen (HLA) Matches   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
0 matches
3
  21.4%
6
  42.9%
9
  32.1%
1 match
4
  28.6%
3
  21.4%
7
  25.0%
2 matches
3
  21.4%
0
   0.0%
3
  10.7%
3 matches
1
   7.1%
1
   7.1%
2
   7.1%
4 matches
1
   7.1%
0
   0.0%
1
   3.6%
5 matches
1
   7.1%
0
   0.0%
1
   3.6%
Missing
1
   7.1%
4
  28.6%
5
  17.9%
[1]
Measure Description: Human Leukocyte Antigen (HLA) testing is done before an organ transplant to find out if tissues match between the donor and the person receiving the transplant.
1.Primary Outcome
Title Number of Participants With New Onset Diabetes After Transplant (NODAT) or Acute Rejection
Hide Description Composite endpoint of biopsy proven acute rejection and NODAT at 6 months post transplantation. NODAT will be defined as either FPG >7.0mmol/L OR symptoms of hyperglycemia and a random plasma glucose of >11.1 OR 2-h plasma glucose >11.1 during an oral glucose tolerance test(OGTT).
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
2
  14.3%
2
  14.3%
2.Secondary Outcome
Title Number of Participant Deaths
Hide Description Death of any participant by end of study.
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Graft Failure
Hide Description Any graft failure by the end of the study.
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With Dialysis Events
Hide Description Any dialysis required by end of study.
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
1
   7.1%
3
  21.4%
5.Secondary Outcome
Title Number of Participants With Infection Events
Hide Description Any infection (CMV, opportunistic infections including urinary tract infections requiring treatment, pneumonia) by end of study.
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
5
  35.7%
5
  35.7%
6.Secondary Outcome
Title Number of Participants With Hospitalization Events
Hide Description Any hospitalization by end of study.
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4
  28.6%
7.Secondary Outcome
Title Number of Participants With Malignancy Events
Hide Description Any malignancy (including post-transplant lymphoproliferative disease) by end of study.
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   7.1%
8.Secondary Outcome
Title Number of Participants With Cardiovascular Event
Hide Description Any cardiovascular events by end of study.
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Any Leukopenia Events
Hide Description Any leukopenia by end of study.
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: events
11 3
10.Secondary Outcome
Title Number of Leukopenia Events on ≥2 Occasions
Hide Description Any leukopenia on ≥2 occasions by end of study.
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: events
6 0
11.Secondary Outcome
Title Change From Baseline in Weight
Hide Description Any changes in weight by end of study.
Time Frame baseline to 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: kg
2.8
(0.8 to 6.8)
1.5
(-1.3 to 3.8)
12.Secondary Outcome
Title eGFR at 6 Months
Hide Description Participant eGFR value by end of study.
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description:

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: mL/min/1.73^2
56
(51 to 81)
51
(43 to 63)
Time Frame Adverse event data was collected from the baseline visit until 6 months post transplant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Hide Arm/Group Description

This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.

Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.

Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

All-Cause Mortality
Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Hide Serious Adverse Events
Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Affected / at Risk (%) Affected / at Risk (%)
Total   7/14 (50.00%)   7/14 (50.00%) 
Immune system disorders     
Malignancy *  1/14 (7.14%)  0/14 (0.00%) 
Infections and infestations     
Infections *  5/14 (35.71%)  5/14 (35.71%) 
Renal and urinary disorders     
Dialysis *  2/14 (14.29%)  2/14 (14.29%) 
Acute Rejection *  1/14 (7.14%)  2/14 (14.29%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Target Tacrolimus (Advagraf) Standard Target Tacrolimus (Advagraf)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
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: Dr. Jagbir Gill
Organization: St. Paul's Hospital
Phone: 6046822344 ext 64706
EMail: JAGill@providencehealth.bc.ca
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Responsible Party: Jagbir Gill, University of British Columbia
ClinicalTrials.gov Identifier: NCT01265537    
Other Study ID Numbers: H10-03047
First Submitted: December 21, 2010
First Posted: December 23, 2010
Results First Submitted: November 27, 2019
Results First Posted: February 11, 2020
Last Update Posted: February 11, 2020