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NCT02711826 · ClinicalTrials.gov registry record · Phase 1
Treg Therapy in Subclinical Inflammation in Kidney Transplantation
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02711826: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02711826 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02711826, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is: * To see if polyTregs can reduce inflammation in a transplanted kidney. * To find out what effects, good or bad, polyTregs will have in the kidney recipient. * To find out what effects, good or bad, taking everolimus after polyTregs will have in the kidney recipient.
Primary Outcome
Acute cell-mediated rejection was defined using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to 2A were determined to have met the endpoint. Severity is graded as 1A, 1B, 2A, 2B, or 3, with 1A being the mildest form of cellular rejection and 3 being the most severe form of cellular rejection. Antibody mediated rejection was defined as diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue i
Interventions
- DRUG Everolimus
- DRUG Tacrolimus
- DRUG Mycophenolate mofetil
- BIOLOGICAL Polyclonal Regulatory T Cells
- DRUG Mycophenolic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-09-20 |
| Est. Completion | 2023-08-04 |
| Phase | Phase 1 |
What the finished NCT02711826 record still lists
NCT02711826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which Everolimus is the first listed.
NCT02711826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02711826 about?
NCT02711826 is a clinical study titled "Treg Therapy in Subclinical Inflammation in Kidney Transplantation". The purpose of this study is: * To see if polyTregs can reduce inflammation in a transplanted kidney. * To find out what effects, good or bad, polyTregs will have in the kidney recipient. * To find out what effects, good or bad, taking everolimus after polyTregs will have in the kidney recipient.
What is the current status of trial NCT02711826?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2016-09-20. Estimated completion is 2023-08-04.
What interventions are being tested in trial NCT02711826?
The interventions under investigation include: Everolimus (DRUG), Tacrolimus (DRUG), Mycophenolate mofetil (DRUG), Polyclonal Regulatory T Cells (BIOLOGICAL), Mycophenolic acid (DRUG).
Who is sponsoring clinical trial NCT02711826?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02711826's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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