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Clinical Trials in the Netherlands / NCT05987527
Active, not recruiting Observational

Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)

NCT05987527 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Sangamo Therapeutics
Phase
Observational
Started
2023-08-15
Last updated
2025-12-04

Condition(s) studied

Kidney Transplant RejectionEnd Stage Renal Disease

Investigational drug(s) / intervention(s)

Blood sample

Blood sample: Routine procedures

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
72 Years
Healthy volunteers
No
Inclusion Criteria: 1. Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study. 2. 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 Criteria: * N/A

Primary outcome measure(s)

  • Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival — Up to 15 years post infusion
    Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival
  • Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0. — Up to 15 years post infusion
    Long term safety and tolerability of TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.

Trial sites (5)

FacilityCityRegionStatus
University Hospitals Leuven Leuven Belgium
University Medical Center Groningen Groningen Netherlands
Leiden University Medical Centre Leiden Netherlands
Erasmus MC, University Medical Center Rotterdam Netherlands
Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom

Other trials for the same condition

A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation Recruiting
The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients Active, not recruiting
Belimumab to Mobilise Memory B-cells From Secondary Lymhoid Organs to Improve Memory B-cell HLA-specificity Profiling to Support Delisting for Transplant Access in Highly-sensitized Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05987527 on ClinicalTrials.gov ↗ ← All trials in the Netherlands