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NCT04311632 · ClinicalTrials.gov registry record · Phase 2
A Dose Escalation Study in de Novo Renal Transplantation
A Phase 2 study, sponsored by ITB-Med.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT04311632: Completed Phase 2 study, sponsored by ITB-Med.
NCT04311632 is a Phase 2 study that has completed, run by ITB-Med. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04311632, a Phase 2 study, has completed, sponsored by ITB-Med.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
Interventions
- DRUG ATG
- DRUG Mycophenolate Mofetil (MMF)
- BIOLOGICAL TCD601
- DRUG Corticosteroids (CS)
- DRUG Tacrolimus (TAC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-05-26 |
| Est. Completion | 2023-10-03 |
| Phase | Phase 2 |
What the finished NCT04311632 record still lists
NCT04311632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which ATG is the first listed.
NCT04311632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04311632 about?
NCT04311632 is a clinical study titled "A Dose Escalation Study in de Novo Renal Transplantation". The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
What is the current status of trial NCT04311632?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2021-05-26. Estimated completion is 2023-10-03.
What interventions are being tested in trial NCT04311632?
The interventions under investigation include: ATG (DRUG), Mycophenolate Mofetil (MMF) (DRUG), TCD601 (BIOLOGICAL), Corticosteroids (CS) (DRUG), Tacrolimus (TAC) (DRUG).
Who is sponsoring clinical trial NCT04311632?
This trial is sponsored by ITB-Med, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04311632's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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