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NCT01318915 · ClinicalTrials.gov registry record · Early Phase 1
Research Study of ATG and Rituximab in Renal Transplantation
A Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT01318915: Clinical Trial Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01318915 is a Early Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01318915, a Early Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given at the time of the transplant surgery, will help reduce or eliminate the need for long term immunosuppressive medication.
Primary Outcome
Participants are considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least 52 weeks without evidence of rejection, as determined by a biopsy performed 52 weeks after completion of immunosuppression withdrawal. All participants who failed to complete immunosuppression withdrawal, regardless of reason, or failed to have a biopsy 52 weeks after completion of immunosuppression withdrawal, were considered to have failed. The endpoint is summarized wi
Interventions
- DRUG Sirolimus
- DRUG Rituximab
- DRUG Tacrolimus
- DRUG ATG
- DRUG MMF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-07-25 |
| Est. Completion | 2017-08-25 |
| Phase | Early Phase 1 |
Why NCT01318915 stopped before completion
NCT01318915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 5 interventions - of which Sirolimus is the first listed.
NCT01318915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01318915 about?
NCT01318915 is a clinical study titled "Research Study of ATG and Rituximab in Renal Transplantation". The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given at the time of the transplant surgery, will help reduce or eliminate the need for long term immunosuppressive medication.
What is the current status of trial NCT01318915?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2011-07-25. Estimated completion is 2017-08-25.
What interventions are being tested in trial NCT01318915?
The interventions under investigation include: Sirolimus (DRUG), Rituximab (DRUG), Tacrolimus (DRUG), ATG (DRUG), MMF (DRUG).
Who is sponsoring clinical trial NCT01318915?
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 NCT01318915's enrollment target sits among peer trials
10 1628th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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