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NCT02495077 · ClinicalTrials.gov registry record · Phase 2
Effects of Inhibiting Early Inflammation in Kidney Transplant Patients
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 290
- Enrollment target
NCT02495077: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02495077 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 290 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (118% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02495077, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 290 participants
- Enrollment target
Study Summary
During transplant surgery, there is a period of time when a donated kidney is removed from a donor's body and stored until the time of the transplant surgery. The storage procedure results in buildup of various proteins within the kidney that can injure the donated kidney after it is transplanted. One of these proteins is tumor necrosis factor-alpha (TNF-alpha). The purpose of this study is to evaluate whether taking infliximab, which blocks tumor necrosis factor alpha (TNF-alpha), just prior to transplant surgery, along with usual transplant medicines will protect the donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy for a longer period of time.
Primary Outcome
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 ind
Interventions
- BIOLOGICAL Infliximab
- DRUG Mycophenolate Mofetil
- DRUG Methylprednisolone
- DRUG Tacrolimus
- BIOLOGICAL Thymoglobulin®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2015-11-02 |
| Est. Completion | 2021-07-23 |
| Phase | Phase 2 |
What the finished NCT02495077 record still lists
NCT02495077 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (118% higher).
The record links to 0 conditions, and to 5 interventions - of which Infliximab is the first listed.
NCT02495077 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02495077 about?
NCT02495077 is a clinical study titled "Effects of Inhibiting Early Inflammation in Kidney Transplant Patients". During transplant surgery, there is a period of time when a donated kidney is removed from a donor's body and stored until the time of the transplant surgery. The storage procedure results in buildup of various proteins within the kidney that can injure the donated kidney after it is transplanted. O...
What is the current status of trial NCT02495077?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 290 participants. The study started on 2015-11-02. Estimated completion is 2021-07-23.
What interventions are being tested in trial NCT02495077?
The interventions under investigation include: Infliximab (BIOLOGICAL), Mycophenolate Mofetil (DRUG), Methylprednisolone (DRUG), Tacrolimus (DRUG), Thymoglobulin® (BIOLOGICAL).
Who is sponsoring clinical trial NCT02495077?
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 NCT02495077's enrollment target sits among peer trials
290 191st of 2000 higher than 1,810 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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