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NCT01976390 · ClinicalTrials.gov registry record · NA
Comparing Everolimus and Sirolimus in Renal Transplant Recipients
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01976390: Completed NA study, sponsored by Ohio State University.
NCT01976390 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01976390, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study is being done to compare the effectiveness and safety of two different kidney transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in the current standard immunosuppression regimen).
Primary Outcome
The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at 1 year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as describe
Interventions
- DRUG Sirolimus
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-10-01 |
| Est. Completion | 2019-08-31 |
| Phase | NA |
What the finished NCT01976390 record still lists
NCT01976390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.
NCT01976390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01976390 about?
NCT01976390 is a clinical study titled "Comparing Everolimus and Sirolimus in Renal Transplant Recipients". This study is being done to compare the effectiveness and safety of two different kidney transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in the current standard immunosuppression regimen).
What is the current status of trial NCT01976390?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2013-10-01. Estimated completion is 2019-08-31.
What interventions are being tested in trial NCT01976390?
The interventions under investigation include: Sirolimus (DRUG), Everolimus (DRUG).
Who is sponsoring clinical trial NCT01976390?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01976390's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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