Kidney and Bone Marrow Transplant for Immunosuppression Withdrawal
This study is testing a new approach to help kidney transplant recipients reduce or stop taking lifelong anti-rejection medications (immunosuppression). It involves a combined kidney and bone marrow transplant from a living donor, along with a special treatment plan called a "conditioning regimen." This regimen includes medications like rituximab, Siplizumab (or ATGAM), cyclophosphamide, and tegoprubart, as well as thymic irradiation. The goal is to achieve "mixed chimerism," where the recipient's body accepts the donor's cells, allowing them to tolerate the new kidney without needing many anti-rejection drugs. Researchers will follow participants for 7 years to see if they can reduce or completely stop their immunosuppression. This study is for adults aged 18-65 with kidney failure who are receiving a first or second kidney transplant from a living donor. The study is currently unclear on its recruitment status and plans to enroll 12 participants.
- Study design
- This is an open-label study at a single institution, meaning both you and your doctors will know what treatments you are receiving. It plans to enroll 12 participants.
- What's involved
- You would undergo a combined kidney and bone marrow transplant, preceded by a six-day conditioning regimen involving various procedures and medications.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for 7 years after the transplant to assess the long-term effects of the treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Tolerance Through Mixed Chimerism (Sip-Tego)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Tatsuo Kawai, MD PhD · PRINCIPAL_INVESTIGATOR · Principal Investigator / Transplant Surgeon
Who to contact
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What this trial measures
- Induction of mixed chimerism without chimeric transition syndrome7 Years
This will be measured by a chimerism level of \>0% donor chimerism at anytime post transplant, and when the level is returning to 0% chimerism there is no evidence of chimeric transition syndrome. This is defined in the protocol by any of the following The clinical symptoms of CTS include acute kidney injury with rapid deterioration of kidney function (elevated creatinine, decreased blood flow to the renal allograft by US), minor to moderate fever, fluid retention or peripheral edema.
- Achievement of IS minimization (tacrolimus or Belatacept monotherapy)7 Years
This will be measured by a patient weaning and maintaining only one agent of immunosuppression (either Tacrolimus or Belatacept)
- Number of patients who complete full immunosuppression withdrawal7 Years
The number (and therefore percentage) of patients who discontinue all immunosuppression (ie. completely stop Tacrolimus or Belatacept)