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Trial record 2 of 2 for:    david sachs

Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection

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: NCT00801632
Recruitment Status : Completed
First Posted : December 3, 2008
Results First Posted : May 12, 2015
Last Update Posted : November 10, 2015
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Kidney Transplantation
Kidney Failure, Chronic
Interventions Procedure: Kidney Transplantation
Procedure: Bone marrow transplantation
Biological: MEDI-507
Drug: cyclophosphamide
Biological: rituximab
Drug: Tacrolimus
Drug: corticosteroids
Radiation: thymic irradiation
Enrollment 5
Recruitment Details Participants with end-stage renal disease and no evidence of prior sensitization were enrolled between December 2008 and September 2009.
Pre-assignment Details  
Arm/Group Title MEDI-507
Hide Arm/Group Description Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Period Title: Overall Study
Started 5
Completed 4
Not Completed 1
Reason Not Completed
Re-transplant             1
Arm/Group Title MEDI-507
Hide Arm/Group Description Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
Intent-to-treat
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
32.8  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
5
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
Baseline Creatinine Level   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 5 participants
1.9  (1.2)
[1]
Measure Description: Baseline creatinine is defined as the lowest serum creatinine collected during the stabilization period or in the 4 weeks following the end of the stabilization period. The stabilization period is defined as 4 consecutive creatinine values close in value (not differing more than 0.3). A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys.
1.Primary Outcome
Title Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks
Hide Description A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first.
Time Frame 48 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title MEDI-507
Hide Arm/Group Description:
Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MEDI-507
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 60.0
Confidence Interval (2-Sided) 95%
14.7 to 94.7
Estimation Comments Clopper-Pearson used to derive confidence interval
2.Secondary Outcome
Title Percentage of Participants Experiencing Acute Rejection
Hide Description The percentage of participants who experience an acute rejection. Acute rejection is defined as a biopsy with findings of Banff score of grade IA or higher. The Banff classification is as follows: grade IA is >25% of parenchyma affected and foci of moderate tubulitis; Grade IB is >25% of parenchyma affected and foci of severe tubulitis; Grade IIA is mild to moderate intimal arteritis; Grade IIB is severe intimal arteritis comprising >25% of the luminal area; Grade III is "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Time Frame Transplantation until study completion or participant termination (up to five years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title MEDI-507
Hide Arm/Group Description:
Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Number of Participants Analyzed 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
40
(5.3 to 85.3)
3.Secondary Outcome
Title Change in Renal Function
Hide Description Change in renal function as seen in serum creatinine values from baseline until study completion or participant termination. Baseline is defined as the lowest serum creatinine collected during stabilization period or in the four weeks following the end of the stabilization period. The stabilization period is defined as four consecutive creatinine values close in value (not differing more than 0.3 mg/dL). Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys.
Time Frame Transplantation until study completion or participant termination (up to five years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title MEDI-507
Hide Arm/Group Description:
Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Serum Creatinine 1.9  (1.2)
Study Termination/Completion 3.2  (2.7)
Change from Baseline 1.2  (1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MEDI-507
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.215
Comments P-value based on a paired t-test comparing baseline creatinine level with the level at study completion/participant termination.
Method t-test, 2 sided
Comments The test describes whether the average of the difference is different from zero.
4.Secondary Outcome
Title Percentage of Participants With Graft Survival Through 156 Weeks
Hide Description The percentage of participants with graft survival from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. Graft survival is defined as the time to week 156 or graft loss. Graft loss is defined as the day on which a graft is deemed irreversibly nonfunctional and dialysis is begun, a transplantectomy is performed, or the participant is re-transplanted, whichever comes first. Six consecutive weeks of dialysis are required for the diagnosis of graft loss, though the date of graft loss will be defined as the date of first dialysis.
Time Frame Transplantation until week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were followed at least three years after transplantation or experienced graft loss prior to week 156
Arm/Group Title MEDI-507
Hide Arm/Group Description:
Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Number of Participants Analyzed 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
80
(28.4 to 99.5)
5.Secondary Outcome
Title Percentage of Participants Surviving Through 156 Weeks
Hide Description The percentage of participants who survived from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded.
Time Frame Transplantation until week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were followed at least three years after transplantation or experienced death prior to week 156
Arm/Group Title MEDI-507
Hide Arm/Group Description:
Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Number of Participants Analyzed 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
100
(39.8 to 100.0)
6.Secondary Outcome
Title Time to Neutrophil Recovery Following Transplant
Hide Description Time (in days) until neutrophil recovery following transplant. Neutrophil recovery is defined as an absolute neutrophil count (ANC) > 500/mm^3 at three consecutive assessments on different days post-transplant. Time to recovery is time from transplantation until the first assessment date used to confirm the recovery.
Time Frame Transplantation until study completion or participant termination (participants followed up to five years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title MEDI-507
Hide Arm/Group Description:
Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: days
14.0  (4.1)
7.Secondary Outcome
Title Time to Platelet Recovery Following Transplant
Hide Description Time (in days) until platelet recovery following transplant. Platelet recovery is defined as a platelet count >20,000 /mm^3 and where no transfusion is required. Time to recovery is time from transplantation until platelet value recovers.
Time Frame Transplantation until study completion or participant termination (participants followed up to five years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title MEDI-507
Hide Arm/Group Description:
Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: days
1.0  (0.0)
8.Secondary Outcome
Title Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection
Hide Description Clinically significant invasive or resistant opportunistic infections include cytomegalovirus, herpes zoster, and candida.
Time Frame Transplantation until study completion or participant termination (participants followed up to five years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title MEDI-507
Hide Arm/Group Description:
Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Number of Participants Analyzed 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0
(0.0 to 52.2)
Time Frame Transplantation until study completion or participant termination (up to five years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MEDI-507
Hide Arm/Group Description Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
All-Cause Mortality
MEDI-507
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
MEDI-507
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  1/5 (20.00%)  1
Thrombotic microangiopathy  1  1/5 (20.00%)  1
Cardiac disorders   
Atrial fibrillation  1  1/5 (20.00%)  1
Gastrointestinal disorders   
Stomatitis  1  1/5 (20.00%)  1
Immune system disorders   
Engraftment syndrome  1  5/5 (100.00%)  5
Transplant rejection  1  2/5 (40.00%)  2
Infections and infestations   
Gastroenteritis  1  1/5 (20.00%)  1
Urinary tract infection  1  1/5 (20.00%)  1
Viral infection  1  1/5 (20.00%)  1
Injury, poisoning and procedural complications   
Post procedural haemorrhage  1  1/5 (20.00%)  1
Investigations   
Blood creatinine increased  1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/5 (20.00%)  1
Vascular disorders   
Haematoma  1  1/5 (20.00%)  1
Thrombosis  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MEDI-507
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  2/5 (40.00%)  2
Neutropenia  1  1/5 (20.00%)  6
Thrombocytopenia  1  3/5 (60.00%)  3
Gastrointestinal disorders   
Diarrhoea  1  1/5 (20.00%)  1
Gastritis  1  1/5 (20.00%)  1
Nausea  1  1/5 (20.00%)  1
Vomiting  1  1/5 (20.00%)  1
General disorders   
Catheter related complication  1  1/5 (20.00%)  1
Pyrexia  1  1/5 (20.00%)  1
Infections and infestations   
Catheter site infection  1  1/5 (20.00%)  1
Clostridium difficile colitis  1  2/5 (40.00%)  2
Urinary tract infection  1  3/5 (60.00%)  4
Injury, poisoning and procedural complications   
Drug toxicity  1  1/5 (20.00%)  1
Limb injury  1  1/5 (20.00%)  1
Investigations   
Alanine aminotransferase increased  1  2/5 (40.00%)  2
Weight increased  1  2/5 (40.00%)  2
Metabolism and nutrition disorders   
Hyperglycaemia  1  1/5 (20.00%)  1
Hyperkalaemia  1  1/5 (20.00%)  1
Hyponatraemia  1  1/5 (20.00%)  1
Hypophosphataemia  1  2/5 (40.00%)  2
Renal and urinary disorders   
Proteinuria  1  4/5 (80.00%)  4
Renal failure acute  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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: Director, Clinical Research Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00801632    
Other Study ID Numbers: DAIT ITN036ST
First Submitted: December 2, 2008
First Posted: December 3, 2008
Results First Submitted: April 21, 2015
Results First Posted: May 12, 2015
Last Update Posted: November 10, 2015