Delayed Tolerance Through Mixed Chimerism (NCT05900401) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Delayed Tolerance Through Mixed Chimerism
United States20 participantsStarted 2023-10-01
Plain-language summary
This study will examine the safety and effectiveness of a bone marrow transplant after kidney transplant (from either a living or deceased 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
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female 18-65 years of age.
✓. Kidney transplant recipients from either LD or DD, with cryo-preserved HSCs available, good renal function (GFR\>60 ml/min/1.73m2), normal current allograft biopsy, and no history of documented rejection episodes.
✓. First or second renal transplant.
✓. Use of FDA-approved methods of contraception (those with less than a 3% failure rate) by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation. (For further information on FDA- approved methods of contraception, see https://www.fda.gov/media/150299/download
✓. Ability to understand and provide informed consent.
✓. Negative COVID-19 test during screening and two days prior to HSC transplantation (HSCT).
✓. Male or female 18-70 years of age.
✓. Consent to donate vertebral bones is obtained from the donor family.
Exclusion criteria
✕. ABO blood group-incompatible renal allograft.
✕. Evidence of anti-HLA antibody (donor specific with an MFI \>1000) as assessed by routine methodology (Luminex)
✕. Previous history of biopsy proven rejection.
✕. Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (\<100,000/mm3).
What they're measuring
1
Incidence of transient mixed chimerism
Timeframe: 3 months
2
Incidence of renal allograft tolerance
Timeframe: 2 years after immunosuppression withdrawal