Status:
COMPLETED
Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Kidney Transplantation
Kidney Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system suppressing medica...
Detailed Description
Organ transplantation is a common procedure in hospitals, but organ rejection and serious side effects are potential problems for the patient. Mycophenolate mofetil, sirolimus, and tacrolimus are drug...
Eligibility Criteria
Inclusion
- Weight greater than 40 kg (88.2 lbs)
- Will be receiving a living-related (1-haplotype-matched donor/recipient) primary kidney allograft
- Negative B-cell and T-cell cytotoxic and flow cytometry crossmatch (1-haplotype-matched donor/recipient pairs with a minimum of 1 HLA DR 1A and 1B locus in common and panel-reactive antibodies \[PRA\] of less than 10%)
- Normal echocardiogram (ECG) with an ejection fraction of greater than 50%
- Received full course of vaccination for hepatitis B virus (HBV), completed at least 6 weeks before transplantation, OR has naturally acquired immunity
- Willing to comply with the study visits
- Willing to use acceptable forms of contraception
Exclusion
- Previously received or is receiving an organ transplant other than a kidney
- Receiving an ABO (blood type) incompatible donor kidney
- Human Immunodeficiency Virus (HIV) infected
- Antibody positive for hepatitis C virus (HCV)
- Surface antigen positive for hepatitis B virus (HBV)
- Recipient or donor is positive for tuberculosis (TB), under treatment for suspected TB, or previously exposed to TB (positive Mantoux test)
- Current cancer or a history of cancer within the 5 years prior to study entry. Patients who have had successfully treated nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are not excluded.
- Significant liver disease, defined as having continuously elevated aspartate aminotransferase (AST SGOT) or alanine aminotransferase (ALT SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry
- Uncontrolled concomitant infections, severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption, active peptic ulcer, or any other unstable medical condition that could interfere with this study
- Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant
- Currently receiving any immunosuppressive agent
- Anticipated contraindication to taking medications orally or via nasogastric tube by the morning of Day 2 following completion of the transplant procedure
- Require certain medications
- Known hypersensitivity to any of the study medications, thymoglobulin daclizumab, or corticosteroids
- Certain screening laboratory values. More information on this criterion can be found in the protocol.
- Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study
- Anticipated contraindication to tacrolimus administration for longer than 5 days post-transplant
- Currently undergoing peritoneal dialysis
- PRA value less than 10% at any time prior to study entry
- Graves disease. Patients with Graves disease adequately treated with radioiodine ablative therapy are not excluded.
- Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) negative kidney recipient receiving a kidney from a CMV or EBV positive donor
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00183248
Start Date
September 1 2004
End Date
November 1 2009
Last Update
October 2 2012
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136