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NCT01653847 · ClinicalTrials.gov registry record · NA
Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
NCT01653847: Completed NA study, sponsored by Northwestern University.
NCT01653847 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 88 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01653847, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
Study Summary
The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking a transplanted organ. The primary purpose of this study is to investigate the impact of two maintenance immunosuppressive regimens. Subjects who enroll in this study will be randomly selected to have tacrolimus and everolimus (group 1) or tacrolimus and mycophenolate mofetil (group 2) as their immunosuppression medication. This study will enroll adult patients who are scheduled to receive a kidney transplant. The study is designed to understand the mechanisms of Everolimus in regards to kidney function in transplant recipients. The investigators hypothesis is that decreased exposure to Tacrolimus to the immune system will then translate in better renal allograft function.
Primary Outcome
Evaluate the change in regulatory T cell generation and review the relationship of the newly generated T cells with their function in the two maintenance immunosuppressive regimens at baseline, 3 and 12 months post-transplant.
Interventions
- DRUG Tacrolimus with MMF
- DRUG Group 2: Tacrolimus with Everolimus.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2013-02 |
| Est. Completion | 2020-05 |
| Phase | NA |
What the finished NCT01653847 record still lists
NCT01653847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus with MMF is the first listed.
NCT01653847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01653847 about?
NCT01653847 is a clinical study titled "Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens". The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking a transplanted organ. The primary purpose o...
What is the current status of trial NCT01653847?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2013-02. Estimated completion is 2020-05.
What interventions are being tested in trial NCT01653847?
The interventions under investigation include: Tacrolimus with MMF (DRUG), Group 2: Tacrolimus with Everolimus. (DRUG).
Who is sponsoring clinical trial NCT01653847?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01653847's enrollment target sits among peer trials
88 972nd of 2000 higher than 1,027 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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