Immunological Tolerance in Patients With Mismatched Kidney Transplants (NCT05806749) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Immunological Tolerance in Patients With Mismatched Kidney Transplants
United States16 participantsStarted 2023-07-07
Plain-language summary
This study seeks to determine if administration of the drug belumosudil (KD025) will be safe and improve transplant tolerance in subjects undergoing combined Human Leukocyte Antigen (HLA) single haplotype-matched related or 0-3 antigen (at A, B, C, DR) HLA mismatched unrelated living donor kidney and hematopoietic stem cell transplantation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 and older
✓. Receiving an HLA single haplotype-matched related living donor or 0-3 antigen (at A, B, C, DR) HLA mismatched unrelated living donor combined kidney and hematopoietic stem cell transplant (the first six subjects will be HLA single haplotype-matched; the final two subjects may be either HLA single-haplotype-matched or 0-3 antigen (at A, B, C, DR) HLA mismatched)
✓. Agreement to participate in the study and ability to give informed consent
✓. Meets institutional criteria for kidney and allogeneic hematopoietic stem cell transplant
✓. Resides or is willing to stay within 3 hours distance from University of California, Los Angeles Medical Center by ground transportation for the first six months post-kidney transplant
✓. No known contraindication to administration of rATG or radiation
✓. If a patient is a female of reproductive potential (i.e. no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status) patient must be confirmed not pregnancy by a serum or urine pregnancy test and must agree to practice a reliable form of contraception including hormonal treatments, barrier methods or intrauterine device for duration of the study
✓. Males of reproductive age must consent to use reliable and effective methods to avoid pregnancy
Exclusion criteria
✕. ABO incompatibility with donor
✕. Previous solid organ transplant
What they're measuring
1
Determine impact of treatment regimen on patient and kidney allograft survival
✕. Previous treatment with rATG or a known allergy to rabbit proteins
✕. Previous treatment with belumosudil (KD025)
✕. History of active malignancy within the past 5 years with the exception of:
✕. Low risk cancer on active surveillance
✕. Malignancy treated with curative intent with no known active disease \>2 years before the first dose of study treatment and of low potential risk of recurrence