Status:
COMPLETED
HLA-Identical Sibling Renal Transplant Tolerance
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Immunosuppression
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to attempt to eliminate the necessity of immunosuppressive therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor hematopoietic stem cel...
Detailed Description
Primary Study Objectives: 1. To remove all immunosuppressive therapy from recipients of HLA-identical sibling renal transplants within 24 months of transplantation. 2. To detect and follow cellular (...
Eligibility Criteria
Inclusion
- Patient fully informed, signed dated Institutional Review Board (IRB)-approved informed consent form obtained directly by the P.I., Co-P.I., or Res. Nurse, and willing to follow study procedures for the duration of study (3 yrs).
- Recipient: a hematocrit of ≥ 33%, and a hemoglobin of ≥ 11.0 g/dL.
- Weight \> 40 kg.
- Primary renal allograft: living related (HLA-identical donor-recipient sibling pairs)
- Negative B-cell and T-cell cytotoxic cross-match, and a low (≤ 10%) Panel Reactive Antibody (PRA) using cytotoxicity.
- Women of childbearing potential: negative qualitative serum pregnancy test.
- Patients studied equivalently as available for transplant using criteria, w/out regard to gender, race, or ethnicity.
- Normal echocardiogram w/ ejection fraction \>50%.
- Male participants w/ reproductive potential agree to use approved methods of birth control during treatment w/ Campath-1H and for minimum of 6 months following last dose. Female participants of childbearing potential agree to use approved methods of birth control for duration of participation in study.
- Patient agrees to follow-up every 2 months after year 3, up to 10 years.
Exclusion
- Patient previously received/receiving transplant other than kidney.
- Patient receiving ABO (blood type) incompatible donor kidney.
- Recipient/donor is ELISA positive for human immunodeficiency virus (HIV), antibody positive for hep. C, or surface antigen positive for hep. B.
- Patient has current malignancy or history of malignancy (within past 5 years), except non-metastatic basal or squa¬mous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been treated successfully.
- Patients w/ significant liver disease, defined as having during past 28 days continuously elevated aspartate aminotransferase (AST (SGOT)) and/or Alanine Aminotransferase (ALT (SGPT)) levels greater than 3 times the upper value of the normal range at this center.
- Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer or other unstable medical condition that could interfere w/ study objectives.
- Patient currently receiving investigational drug or received an investigational drug within 30 days pre-transplant.
- Patient currently receiving immunosuppressive agent.
- In investigator's judgment, anticipated that patient unable to take medications orally or via nasogastric tube by morning of second day (i.e., skin closure).
- Concurrent use of warfarin, fluvastatin, astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
- Patient hypersensitivity to tacrolimus, Campath-1H, Thymoglobulin, daclizumab (Zenapax®), sirolimus, MMF or corticosteroids.
- Patient pregnant or lactating.
- Patients w/ screening/baseline total white blood cell count \<4000/mm3; platelet count \<100,000/mm3; fasting triglycerides \>400 mg/dl (\>4.6 mmol/L); fasting total cholesterol \>300 mg/dl (\>7.8 mmol/L); fasting HDL-cholesterol \<30 mg/dl; fasting LDL-cholesterol \>200 mg/dl.
- Patient unlikely to comply w/ visits.
- Patient w/ any form of substance abuse, psychiatric disorder or condition that, in investigator's opinion, may invalidate communication.
- Expected that tacrolimus cannot be instituted for over 5 days post-operatively.
- Patients w/ cytotoxic PRA value \>10% any time pre-enrollment.
- Patients w/ Graves disease, unless previously treated w/ radioiodine ablative therapy.
- History of idiopathic thrombocytopenic purpura (ITP) or thrombotic thrombocytopenic purpura (TTP)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00619528
Start Date
January 1 2008
End Date
September 1 2023
Last Update
August 11 2025
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611