Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients (NCT00183248) | Clinical Trial Compass
CompletedPhase 1/2
Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients
United States9 participantsStarted 2004-09
Plain-language 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 medications with or without infusions of bone marrow stem cells from the kidney donor. The purpose of this study is to find out which strategy is more effective in preventing organ rejection and maintaining patient health.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 al…
What they're measuring
1
Overall Participant Survival at One Year Post Kidney Transplant
Timeframe: One year post kidney transplant
2
Overall Kidney Graft Survival at One Year Post-Transplant