Status:
ACTIVE_NOT_RECRUITING
Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)
Lead Sponsor:
Sangamo Therapeutics
Conditions:
Kidney Transplant Rejection
End Stage Renal Disease
Eligibility:
All Genders
18-72 years
Brief Summary
This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.
Detailed Description
This is long- term follow up observational trial for patients who participated previously to a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of autologous, chimeri...
Eligibility Criteria
Inclusion
- Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.
- Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.
Exclusion
- N/A
Key Trial Info
Start Date :
August 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 11 2039
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05987527
Start Date
August 15 2023
End Date
June 11 2039
Last Update
December 4 2025
Active Locations (5)
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1
University Hospitals Leuven
Leuven, Belgium
2
University Medical Center Groningen
Groningen, Netherlands
3
Leiden University Medical Centre
Leiden, Netherlands
4
Erasmus MC, University Medical Center
Rotterdam, Netherlands