Phase 2
Completed N=5
Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection
Chronic Kidney Disease · Kidney Failure, Chronic
Source: ClinicalTrials.gov NCT00801632 ↗
Enrolled (actual)
5
Serious AEs
100.0%
Results posted
May 2015
Primary outcomePrimary: Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks — 3 participants
Summary
In small initial studies, combined kidney and bone marrow transplants from the same donor have permitted some individuals to stop taking anti-rejection medicines without rejecting their transplant. This clinical trial will study this method in a greater number of people to determine if it is indeed effective and safe.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks |
3 | — |
| SECONDARY Percentage of Participants Experiencing Acute Rejection |
40 | — |
| SECONDARY Change in Renal Function |
1.9; 3.2; 1.2 | 0.215 |
| SECONDARY Percentage of Participants With Graft Survival Through 156 Weeks |
80 | — |
| SECONDARY Percentage of Participants Surviving Through 156 Weeks |
100 | — |
| SECONDARY Time to Neutrophil Recovery Following Transplant |
14.0 | — |
| SECONDARY Time to Platelet Recovery Following Transplant |
1.0 | — |
| SECONDARY Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection |
— | — |
Eligibility Criteria
Inclusion Criteria
- Awaiting first or second transplant with a living donor or first transplant with a cadaveric donor
- For living-donor transplants, must have one or more HLA antigen-mismatched donors identified
- Serologic evidence of prior exposure to Epstein-Barr virus (EBV)
Exclusion Criteria
- ABO blood group-incompatibility for a kidney graft of tissue from a donor
- Decreased circulating white blood cell count
- Positive for HIV-1, hepatitis B and C viruses
- Have had prior radiation therapy that could limit dose
- Lung capacity <50% of predicted normal
- Evidence of insufficient cardiac capacity
- Unwilling to use adequate contraception until 2 years after transplant
- Lactation or pregnancy
- Presence of antibody against the donor
Data sourced from ClinicalTrials.gov (NCT00801632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.