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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 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.

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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.

Interventions

  • DRUG Placebo
  • DRUG C1 Esterase Inhibitor

Study Locations (1)

California

  • Cedars-Sinai Medical Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2014-09
Est. Completion 2017-03-13
Phase Phase 1

Sponsor

Cedars-Sinai Medical Center

339 total trials

What the Registry Record Tells You About NCT02134314

The ClinicalTrials.gov registry entry for NCT02134314 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (92% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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