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NCT02134314 · ClinicalTrials.gov registry record · Phase 1
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
A Phase 1 study of End Stage Renal Disease and Kidney Failure, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT02134314: Completed Phase 1 study of End Stage Renal Disease and Kidney Failure, sponsored by Cedars-Sinai Medical Center.
NCT02134314 is a Phase 1 study of End Stage Renal Disease and Kidney Failure that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 70 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02134314, a Phase 1 study of End Stage Renal Disease and Kidney Failure, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
The use of C1INH (Berinert) in patients receiving deceased donor kidney transplants with high risk for delayed graft function (DGF) may show significant improvement in outcomes post transplant compared with patients that do not receive C1INH treatment. Complement activation has been detected in animal models and human kidneys with ischemic reperfusion injury (IRI) and inflammatory cell infiltrates. By blocking complement activation the investigators hope to improve kidney graft function post transplant in these recipients.
Primary Outcome
Number of participants in the C1INH and placebo groups with serum creatinine \>3mg/dL on postoperative day 5
Conditions Studied
Interventions
- DRUG Placebo
- DRUG C1 Esterase Inhibitor
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2014-09 |
| Est. Completion | 2017-03-13 |
| Phase | Phase 1 |
What the finished NCT02134314 record still lists
NCT02134314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02134314 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02134314 about?
NCT02134314 is a clinical study titled "C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI". The use of C1INH (Berinert) in patients receiving deceased donor kidney transplants with high risk for delayed graft function (DGF) may show significant improvement in outcomes post transplant compared with patients that do not receive C1INH treatment. Complement activation has been detected in anim...
What is the current status of trial NCT02134314?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2014-09. Estimated completion is 2017-03-13.
What conditions does trial NCT02134314 study?
This clinical trial studies the following conditions: End Stage Renal Disease, Kidney Failure, Delayed Graft Function, Ischemic Reperfusion Injury.
What interventions are being tested in trial NCT02134314?
The interventions under investigation include: Placebo (DRUG), C1 Esterase Inhibitor (DRUG).
Who is sponsoring clinical trial NCT02134314?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02134314 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02134314's enrollment target sits among peer trials
70 43rd of 86 higher than 44 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease 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.
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