Trial Outcomes & Findings for HLA-Identical Sibling Renal Transplant Tolerance (NCT NCT00619528)
NCT ID: NCT00619528
Last Updated: 2025-08-11
Results Overview
The ability to withdraw immunosuppression as above 24 months post-transplant with follow-up to 10 years.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
24 months post-transplant with follow-up to 10 years
Results posted on
2025-08-11
Participant Flow
Subject enrollment 2008-2012. Subjects were recruited at the Northwestern University Medical Center, in the comprehensive Transplant Center. Enrollment has been completed since 2012
1 subject did not did not receive the DHSC infusions due to the immediate pre-operative cross-match again the donor that was unexpectedly found to be positive
Participant milestones
| Measure |
Experimental
Recipients of Infusion of Donor Hemopoietic Steam Cells (n=20)
|
Donor
Donor of HLA identical donor-recipient sibling pairs
|
Healthy Controls
Healthy Controls do not have the disease or problem being studied.
|
Parents of Recipients/Donors
Parent(s) to donor/recipient children
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
19
|
29
|
|
Overall Study
COMPLETED
|
19
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
20
|
19
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HLA-Identical Sibling Renal Transplant Tolerance
Baseline characteristics by cohort
| Measure |
Recipients
n=20 Participants
Recipient of kidney transplant
|
Donor
n=20 Participants
Donating kidney to sibling
|
Healthy Controls
n=19 Participants
The control subjects (not having the disease or problem being studied) either have a one time bone marrow aspiration (taking bone marrow out of one or both hip bones) and/or having blood taken for the study.
|
Parents of Recipients/Donors
n=29 Participants
The subjects in this group are the parents of donors and recipients of kidney transplant
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.625 years
n=5 Participants
|
39.241 years
n=7 Participants
|
36.034 years
n=5 Participants
|
53.379 years
n=4 Participants
|
36.034 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 months post-transplant with follow-up to 10 yearsThe ability to withdraw immunosuppression as above 24 months post-transplant with follow-up to 10 years.
Outcome measures
| Measure |
Kidney Transplant Recipients Who Received Infusion of Donor Hematopoietic Stem Cells and Campath-1H
n=19 Participants
No separate arms: All Enrolled Receive Same Treatment
Infusion of Donor Hematopoietic Stem Cells and Campath-1H: Intervention: a four-dose (peri-operative and 3, 6, and 9-month boost) DHSC infusion protocol using two-dose Campath-1H induction combined with transient (conditioning) Tacrolimus/Sirolimus and MMF therapy will result in a high degree of macro-chimerism (\>10%), and a robust prolonged donor-specific (post-thymic) immunoregulatory condition that will allow renal transplant survival in the absence of permanent immunosuppression.
|
|---|---|
|
The Ability to Withdraw Immunosuppression as Above 24 Months Post-transplant
|
6 Participants
|
PRIMARY outcome
Timeframe: One YearPatient and graft survival measured at the one-year timepoint post-transplant.
Outcome measures
| Measure |
Kidney Transplant Recipients Who Received Infusion of Donor Hematopoietic Stem Cells and Campath-1H
n=20 Participants
No separate arms: All Enrolled Receive Same Treatment
Infusion of Donor Hematopoietic Stem Cells and Campath-1H: Intervention: a four-dose (peri-operative and 3, 6, and 9-month boost) DHSC infusion protocol using two-dose Campath-1H induction combined with transient (conditioning) Tacrolimus/Sirolimus and MMF therapy will result in a high degree of macro-chimerism (\>10%), and a robust prolonged donor-specific (post-thymic) immunoregulatory condition that will allow renal transplant survival in the absence of permanent immunosuppression.
|
|---|---|
|
Patient and Graft Survival
|
20 Participants
|
Adverse Events
Recipient of Transplant
Serious events: 8 serious events
Other events: 4 other events
Deaths: 4 deaths
Donor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parents of Recipients/Donors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Recipient of Transplant
n=20 participants at risk
Recipient with Infusion of Donor Hematopoietic Stem Cells and Campath-1H:
|
Donor
n=20 participants at risk
Donating Kidney to Sibling
|
Healthy Controls
n=19 participants at risk
Control subjects (not having the disease or problem being studied) either have at one time bone marrow aspiration (taking bone marrow out of one or both hip bones) and/or having blood taken for the study
|
Parents of Recipients/Donors
n=29 participants at risk
The subjects in this group are the parents of the donor and recipient of kidney transplant
|
|---|---|---|---|---|
|
Endocrine disorders
Pancreatic Neuroendocrine Tumor
|
5.0%
1/20 • Number of events 1 • Over 10 year after receiving consenting to the study
|
0.00%
0/20 • Over 10 year after receiving consenting to the study
|
0.00%
0/19 • Over 10 year after receiving consenting to the study
|
0.00%
0/29 • Over 10 year after receiving consenting to the study
|
|
Renal and urinary disorders
Prostrate Cancer
|
5.0%
1/20 • Number of events 1 • Over 10 year after receiving consenting to the study
|
0.00%
0/20 • Over 10 year after receiving consenting to the study
|
0.00%
0/19 • Over 10 year after receiving consenting to the study
|
0.00%
0/29 • Over 10 year after receiving consenting to the study
|
|
General disorders
Hospitalizations
|
20.0%
4/20 • Number of events 4 • Over 10 year after receiving consenting to the study
|
0.00%
0/20 • Over 10 year after receiving consenting to the study
|
0.00%
0/19 • Over 10 year after receiving consenting to the study
|
0.00%
0/29 • Over 10 year after receiving consenting to the study
|
|
Renal and urinary disorders
Acute Tubular Necrosis
|
5.0%
1/20 • Number of events 1 • Over 10 year after receiving consenting to the study
|
0.00%
0/20 • Over 10 year after receiving consenting to the study
|
0.00%
0/19 • Over 10 year after receiving consenting to the study
|
0.00%
0/29 • Over 10 year after receiving consenting to the study
|
|
Renal and urinary disorders
Severe Cellular Rejection
|
5.0%
1/20 • Number of events 1 • Over 10 year after receiving consenting to the study
|
0.00%
0/20 • Over 10 year after receiving consenting to the study
|
0.00%
0/19 • Over 10 year after receiving consenting to the study
|
0.00%
0/29 • Over 10 year after receiving consenting to the study
|
|
Cardiac disorders
Heart Failure
|
5.0%
1/20 • Number of events 1 • Over 10 year after receiving consenting to the study
|
0.00%
0/20 • Over 10 year after receiving consenting to the study
|
0.00%
0/19 • Over 10 year after receiving consenting to the study
|
0.00%
0/29 • Over 10 year after receiving consenting to the study
|
Other adverse events
| Measure |
Recipient of Transplant
n=20 participants at risk
Recipient with Infusion of Donor Hematopoietic Stem Cells and Campath-1H:
|
Donor
n=20 participants at risk
Donating Kidney to Sibling
|
Healthy Controls
n=19 participants at risk
Control subjects (not having the disease or problem being studied) either have at one time bone marrow aspiration (taking bone marrow out of one or both hip bones) and/or having blood taken for the study
|
Parents of Recipients/Donors
n=29 participants at risk
The subjects in this group are the parents of the donor and recipient of kidney transplant
|
|---|---|---|---|---|
|
Renal and urinary disorders
UTI
|
5.0%
1/20 • Number of events 1 • Over 10 year after receiving consenting to the study
|
0.00%
0/20 • Over 10 year after receiving consenting to the study
|
0.00%
0/19 • Over 10 year after receiving consenting to the study
|
0.00%
0/29 • Over 10 year after receiving consenting to the study
|
|
Product Issues
Allergic Reaction following second dose of Altuzemab
|
15.0%
3/20 • Number of events 3 • Over 10 year after receiving consenting to the study
|
0.00%
0/20 • Over 10 year after receiving consenting to the study
|
0.00%
0/19 • Over 10 year after receiving consenting to the study
|
0.00%
0/29 • Over 10 year after receiving consenting to the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place