Sip-Tego Regimen for Kidney Failure

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Tatsuo Kawai, MD, PhD

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.

Research Team

Tatsuo Kawai, MD PhD

Principal Investigator

Principal Investigator / Transplant Surgeon

Eligibility Criteria

This trial is for adults with end-stage renal disease who need a kidney transplant and have no prior sensitization. It's not specified, but typically participants should be healthy enough to undergo the procedures and not have conditions that would exclude them from safely participating.

Inclusion Criteria

Negative COVID-19 test during screening and two days prior to procedure

I will use approved birth control methods for 24 months after my kidney transplant.

I can understand and agree to the study's details.

Exclusion Criteria

Enrollment in other investigational drug studies within 30 days prior to enrollment

Participant with a donor-specific antibody (DSA) within 6 months prior to transplant

Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (<100,000/mm3)

Treatment Details

Interventions

• Cyclophosphamide
• Siplizumab

Trial Overview The study tests a new approach called Sip-Tego, which includes receiving both a kidney and bone marrow from the same donor, along with medications (Rituxan, Siplizumab, Cyclophosphamide, Tegoprubart) to encourage immune tolerance of the new organ.

Participant Groups

Group I: Recipient Experimental Treatment 2 Interventions

Recipient of kidney and bone marrow transplant

Group II: Donor Experimental Treatment 1 Intervention

Living donors of kidney and bone marrow transplant

Who Is Running the Clinical Trial?

Tatsuo Kawai, MD, PhD

Lead Sponsor

Eledon Pharmaceuticals

Industry Sponsor

Trials

5

Recruited

300+

ITB-Med LLC

Industry Sponsor

Trials

12

Recruited

390+