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NCT01517984 · ClinicalTrials.gov registry record · Phase 2
Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT01517984: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01517984 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01517984, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
The study will compare how well transplanted kidneys work and the response of people's immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn. In addition, this research study will evaluate whether reducing immunosuppression can decrease some of these side effects while still preventing rejection of the kidney.
Primary Outcome
The investigators were not able to assess this outcome, the effect of the intervention on interstitial fibrosis/tubular atrophy (IF/TA; on a 2-year graft biopsy) due to the study's premature termination by the Data Safety Monitoring Board (DSMB) because of absence of equipoise on the basis of predetermined stopping rules.
Interventions
- DRUG Tacrolimus (CNI) Withdrawal
- DRUG Standard Immunosuppressive Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2010-11 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
Why NCT01517984 stopped before completion
NCT01517984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus (CNI) Withdrawal is the first listed.
NCT01517984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01517984 about?
NCT01517984 is a clinical study titled "Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation". The study will compare how well transplanted kidneys work and the response of people's immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn. In addition, this research study will evaluate whether reducing immunosuppression can decrease some of these side effects while still prev...
What is the current status of trial NCT01517984?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2010-11. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01517984?
The interventions under investigation include: Tacrolimus (CNI) Withdrawal (DRUG), Standard Immunosuppressive Therapy (DRUG).
Who is sponsoring clinical trial NCT01517984?
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 NCT01517984's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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