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NCT05669001 · ClinicalTrials.gov registry record · Phase 2
A Study of TCD601 in de Novo Renal Transplant Recipients
A Phase 2 study of Renal Transplantation, sponsored by ITB-Med.
- Active
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 17
- Study locations
NCT05669001: Active Phase 2 study of Renal Transplantation, sponsored by ITB-Med.
NCT05669001 is a Phase 2 study of Renal Transplantation that is active but no longer recruiting, run by ITB-Med. The registered enrollment target is 76 participants, above the 40-participant average among 7 other Renal Transplantation trials with a reported enrollment target (90% higher). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05669001, a Phase 2 study of Renal Transplantation, is active but no longer recruiting, sponsored by ITB-Med.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.
Primary Outcome
The number of adverse events and serious adverse events
Conditions Studied
Interventions
- DRUG ATG
- BIOLOGICAL belatacept
- BIOLOGICAL TCD601
- DRUG TAC
- DRUG MPA
Study Locations (17)
California
- University of California Davis Medical Center - Sacramento
- University of California San Francisco Medical Center - San Francisco
Illinois
- Northwestern University - Chicago
- Loyola University Medical Center - Maywood
Virginia
- University of Virginia Health - Charlottesville
- Inova Fairfax Hospital Medical Campus - Falls Church
Florida
- Tampa General Hospital - Tampa
Georgia
- Emory University Hospital - Atlanta
Louisiana
- Ochsner Clinic Foundation - New Orleans
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2023-12-28 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What the registry record for NCT05669001 still lists
NCT05669001 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 40-participant average among 7 other Renal Transplantation trials with a reported enrollment target (90% higher).
The record links to 1 condition, with Renal Transplantation appearing as the primary indexed condition, and to 5 interventions - of which ATG is the first listed.
NCT05669001 lists 17 locations in 14 states (California, Illinois, Virginia).
Frequently Asked Questions
What is clinical trial NCT05669001 about?
NCT05669001 is a clinical study titled "A Study of TCD601 in de Novo Renal Transplant Recipients". The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.
What is the current status of trial NCT05669001?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2023-12-28. Estimated completion is 2026-04.
What conditions does trial NCT05669001 study?
This clinical trial studies the following conditions: Renal Transplantation.
What interventions are being tested in trial NCT05669001?
The interventions under investigation include: ATG (DRUG), belatacept (BIOLOGICAL), TCD601 (BIOLOGICAL), TAC (DRUG), MPA (DRUG).
Who is sponsoring clinical trial NCT05669001?
This trial is sponsored by ITB-Med, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05669001 being conducted?
This trial has 17 study locations across California, Florida, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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