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NCT06972069 · ClinicalTrials.gov registry record · Early Phase 1
Tolerance Through Mixed Chimerism (Sip-Tego)
A Early Phase 1 study of Kidney Failure and Transplant Recipient (Kidney), sponsored by Tatsuo Kawai, MD, PhD.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06972069: Recruiting Early Phase 1 study of Kidney Failure and Transplant Recipient (Kidney), sponsored by Tatsuo Kawai, MD, PhD.
NCT06972069 is a Early Phase 1 study of Kidney Failure and Transplant Recipient (Kidney) that is actively recruiting participants, run by Tatsuo Kawai, MD, PhD. The registered enrollment target is 12 participants, below the 587-participant average among 18 other Kidney Failure trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06972069, a Early Phase 1 study of Kidney Failure and Transplant Recipient (Kidney), is actively recruiting participants, sponsored by Tatsuo Kawai, MD, PhD.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Combined Kidney/Bone Marrow Transplant
- PROCEDURE Donation of Kidney / Bone Marrow
- DRUG Conditioning Regimen (Rituxan, Siplizumab, Cyclophosphamide, Tegoprubart)
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-05-31 |
| Est. Completion | 2030-12-31 |
| Phase | Early Phase 1 |
What NCT06972069 shows while recruiting
NCT06972069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 587-participant average among 18 other Kidney Failure trials with a reported enrollment target (98% lower).
The record links to 5 conditions, with Kidney Failure appearing as the primary indexed condition, and to 3 interventions - of which Combined Kidney/Bone Marrow Transplant is the first listed.
NCT06972069 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06972069 about?
NCT06972069 is a clinical study titled "Tolerance Through Mixed Chimerism (Sip-Tego)". 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 demons...
What is the current status of trial NCT06972069?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2025-05-31. Estimated completion is 2030-12-31.
What conditions does trial NCT06972069 study?
This clinical trial studies the following conditions: Kidney Failure, Transplant Recipient (Kidney), Transplant Tolerance, Immunosuppresion, Immunosuppression After Kidney Transplantation.
What interventions are being tested in trial NCT06972069?
The interventions under investigation include: Combined Kidney/Bone Marrow Transplant (PROCEDURE), Donation of Kidney / Bone Marrow (PROCEDURE), Conditioning Regimen (Rituxan, Siplizumab, Cyclophosphamide, Tegoprubart) (DRUG).
Who is sponsoring clinical trial NCT06972069?
This trial is sponsored by Tatsuo Kawai, MD, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06972069 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06972069's enrollment target sits among peer trials
12 16th of 18 higher than 1 of 18 other Kidney Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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