HLA-Identical Sibling Renal Transplant Tolerance

Completed · Not applicable

Conditions studied: Immunosuppression, Kidney Transplantation, Graft Rejection

In brief

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 cell (DHSC) lineages for pairs to demonstrate immunologic unresponsiveness, and to investigate the safety and efficacy of the treatment regimen including withdrawal of immunosuppression after one year post-transplant for those recipients having received DHSC infusions.

Key facts

Study ID

NCT00619528

Run by

Northwestern University

People needed

88

Starts

2008-01-01

Expected to finish

2023-09-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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