Immunological Tolerance Therapy for Kidney Transplant Rejection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if Belumosudil can help kidney transplant patients accept their new kidney without long-term immune-suppressing drugs. It targets patients with partially matched or slightly mismatched donors. The drug works by boosting special immune cells that help the body accept the new kidney.
Do I need to stop my current medications to join the trial?
The trial requires that you have not taken immunosuppressive medications within one year of the study treatment, except for short-term corticosteroids that were stopped at least 4 weeks before the kidney transplant. Other specific medication restrictions are not mentioned, so it's best to discuss your current medications with the study team.
Is the treatment generally safe for humans?
The research does not provide specific safety data for the treatment under the names Belumosudil, Rezurock, Rholistiq, KD025, SLx-2119, Donor CD34+, or CD3+. However, it mentions that some immunosuppressive therapies in kidney transplantation have been associated with toxicities, and safety issues have led to the discontinuation of certain treatments in the past.12345
What makes the treatment Belumosudil, Donor CD34+, CD3+ unique for kidney transplant rejection?
This treatment is unique because it combines Belumosudil, which is known for its use in other conditions like chronic graft-versus-host disease, with donor cell therapy (CD34+ and CD3+ cells) to potentially induce immune tolerance, reducing the need for long-term immunosuppressive drugs that can have significant side effects.678910
Are You a Good Fit for This Trial?
Adults over 18 eligible for kidney and stem cell transplants can join this trial if they have a matched living donor, are not pregnant, agree to use contraception, live near UCLA Medical Center, and have good heart, liver, and lung function. Excluded are those with certain infections or diseases requiring immunosuppression, recent drug abuse history, very high BMI or previous organ transplants.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning and Transplantation
Subjects undergo a conditioning regimen of rATG and TLI followed by kidney transplantation and infusion of donor CD34 and CD3 cells.
Treatment
Participants receive a triple immunosuppressive regimen and belumosudil. Corticosteroids taper from day 0 to month 4, tacrolimus taper from day 1 to month 18, and mycophenolate from day 11 to month 12. Belumosudil is administered from day 28 to month 24.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including chimerism measurement, graft function monitoring, and protocol biopsies.
What Are the Treatments Tested in This Trial?
Interventions
- Belumosudil
- Donor CD34+, CD3+
Belumosudil is already approved in United States, Canada for the following indications:
- Chronic graft-versus-host disease (cGVHD) in patients aged 12 years and older after failure of at least two prior lines of systemic therapy
- Chronic graft-versus-host disease (cGVHD) in adult and pediatric patients 12 years or older
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor