Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant
Completed · Phase 1
Conditions studied: End-stage Renal Disease, Renal Transplantation, Kidney Transplantation
In brief
This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a relative with the same (or nearly the same) blood cell type as the transplant recipient. An investigational medication will be given prior to and after the transplant to help protect the transplanted kidney from attack by the body's immune system.
Key facts
- Study ID
- NCT00063817
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 5
- Starts
- 2003-06-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2017-12-27
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- End-stage renal disease (ESRD) without prior sensitization (defined as Panel Reactive Antibody [PRA] greater than 20%) within the 60 days prior to transplant as measured by cytotoxicity assays, ELISA, and flow cytometry;
- Undergoing a first or second transplant;
- Receiving a transplant from a living related donor who is ABO (blood type) compatible and haploidentical (3, 4, or 5 antigen match by serologic typing);
- Cardiac ejection fraction greater than 40%;
- Forced expiratory volume (FEV1) greater than 50%;
- Liver function tests, bilirubin, and coagulation studies less than 2 X normal;
- White blood cells greater than 2000/mm\^3; abd
- Platelets greater than 100,000/mm\^3
You may not qualify if…
- Positive donor lymphocyte cross-match;
- HIV-1 infected;
- Positive hepatitis B surface antigen (HbsAg);
- Hepatitis C virus infected;
- History of cancer;
- Prior dose-limiting radiation therapy;
- Pregnant, breastfeeding, or planning pregnancy within the time frame of the study;
- Enrolled in another investigational drug study within 30 days prior to study entry; or
- Receiving maintenance immunosuppression within 3 months before the conditioning regimen begins
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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