RecruitingEarly Phase 1

Tolerance Through Mixed Chimerism (Sip-Tego)

United States12 participantsStarted 2025-05-31

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female 18-65 years of age.
✓. Subjects with chronic kidney disease stage V (GFR\<15ml/min/1.73m2) or ESRD who are treated or imminently be treated with either hemodialysis or peritoneal dialysis.
✓. Candidate for a living-donor renal allograft from an HLA matched or mismatched donor
✓. First or second renal transplant.
✓. EBV Seropositive
✓. 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.
✓. Negative COVID-19 test during screening and two days prior to procedure

Exclusion criteria

✕. ABO blood group-incompatible renal allograft
✕. 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)
✕. Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA); or positivity for hepatitis B surface antigen.
✕

What they're measuring

Induction of mixed chimerism without chimeric transition syndrome

Timeframe: 7 Years

Achievement of IS minimization (tacrolimus or Belatacept monotherapy)

Timeframe: 7 Years

Number of patients who complete full immunosuppression withdrawal

Timeframe: 7 Years

Trial details

NCT IDNCT06972069

SponsorTatsuo Kawai, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

Contact for this trial

Kerry Augusta, RN

617-724-8570 kaugusta@mgb.org

View on ClinicalTrials.gov More Kidney Failure trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female 18-65 years of age.
✓. Subjects with chronic kidney disease stage V (GFR\<15ml/min/1.73m2) or ESRD who are treated or imminently be treated with either hemodialysis or peritoneal dialysis.
✓. Candidate for a living-donor renal allograft from an HLA matched or mismatched donor
✓. First or second renal transplant.
✓. EBV Seropositive
✓. 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.
✓. Negative COVID-19 test during screening and two days prior to procedure

Exclusion criteria

✕. ABO blood group-incompatible renal allograft
✕. 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)
✕. Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA); or positivity for hepatitis B surface antigen.
✕