Phase 2
N=2
Renal Allograft Tolerance Through Mixed Chimerism
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01780454 ↗Enrolled (actual)
2
Serious AEs
50.0%
Results posted
Sep 2020
Primary outcome: Primary: Successful Withdrawal of Immunosuppressive Therapy — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEDI-507 (Drug); Rituximab (Drug); Total Body Irradiation (Radiation); Thymic Irradiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Withdrawal of Immunosuppressive Therapy |
2 | — |
| SECONDARY Number of Participants With Engraftment Syndrome |
2 | — |
Summary
This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a haplo-identical related donor. An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system
Eligibility Criteria
Key Inclusion Criteria
- Male or female 18-60 years of age
- Candidate for a living-donor renal allograft with a one haplotype identical donor identified.
- First or second transplant with either a living donor or cadaveric transplant as the first transplant.
- Positive serologic testing for EBV indicating past exposure.
Key Exclusion Criteria
- ABO blood group-incompatible renal allograft.
- Evidence of anti-HLA antibody within 60 days prior to transplant as assessed by routine methodology (AHG and/or ELISA)
- Positive testing for: HIV, hepatitis B core antigen, or hepatitis C virus or positivity for hepatitis B surface antigen.
- Cardiac ejection fraction 2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT).
- The presence of any medical condition that the investigator deems incompatible with participation in the trial.
Data sourced from ClinicalTrials.gov (NCT01780454). 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.