Phase 1
N=2
Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)
Kidney Failure, Chronic · Renal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT02314403 ↗Enrolled (actual)
2
Serious AEs
50.0%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participants With Successful Withdrawal of Immunosuppression — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Belatacept (Drug); ATG (Drug); Rituximab (Drug); Total Body Irradiation (Radiation); Thymic Irradiation (Radiation); Combined Bone Marrow/Kidney Transplantation (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Withdrawal of Immunosuppression |
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
Inclusion Criteria
- Male or female 18-60 years of age
- Candidate for a living-donor renal allograft from an HLA mismatched donor
- First or second transplant with either a living donor or cadaveric transplant as the first transplant.
- Use of FDA-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation.
- Ability to understand and provide informed consent.
- Serologic evidence of prior exposure to EBV.
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)
- Leukopenia or thrombocytopenia.
- Positive for HIV-1, 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).
- Allergy or sensitivity to any component of belatacept, ATG, tacrolimus, or rituximab.
- Maintenance immunosuppression within 3 months prior to conditioning other than physiological doses of steroids, defined as ≤ 50 mg of hydrocortisone or dose equivalent.
- The presence of any medical condition that the investigator deems incompatible with participation in the trial.
Data sourced from ClinicalTrials.gov (NCT02314403). 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.