HLA-Identical Sibling Renal Transplant Tolerance With Donor Hematopoietic Stem Cells and Campath-1H
- Patient fully informed, signed dated 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%) PRA using
- 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.
- Patient previously received/receiving transplant other than kidney.
- Patient receiving ABO 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 AST (SGOT) and/or 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
- History of ITP or TTP