Who is sponsoring C1INHDGF?

C1INHDGF is sponsored by Cedars-Sinai Medical Center.

What condition does C1INHDGF study?

C1INHDGF studies End Stage Renal Disease, Kidney Failure, Delayed Graft Function, Ischemic Reperfusion Injury.

What drugs are being tested in C1INHDGF?

Interventions: C1 Esterase Inhibitor, Placebo.

What is the status of C1INHDGF?

C1INHDGF is currently COMPLETED.

Last reviewed 2018-06-20 · How we verify

Assessing Safety and Efficacy of Preoperative and Post-Transplant C1 Inhibitor (Berinert®) vs. Placebo in Recipients of a Renal Allograft From Deceased High Risk Donors and Its Impact on DGF and IRI (C1INHDGF)

NCT02134314 Phase 1/Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Cedars-Sinai Medical Center
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	70
Start date	2014-09
Completion	2017-03-13

Conditions

End Stage Renal Disease
Kidney Failure
Delayed Graft Function
Ischemic Reperfusion Injury

Interventions

C1 Esterase Inhibitor
Placebo

Primary outcomes

Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5. — First 7 days post-transplant
Number of participants in the C1INH and placebo groups with serum creatinine \>3mg/dL on postoperative day 5
Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant. — First 7 days post-transplant
The proportion of patients enrolled who require at least one session of dialysis in the first 7 days post transplant (excluding those who are dialyzed for hyperkalemia).
Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant. — First 7 days post-transplant
Number of patients in the C1INH and placebo groups with serum creatinine reduction of \< 30% from 24 to 48 hours post-transplant.
Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant. — First 7 days post-transplant
Mean quantity of dialysis sessions per patient in the first 7 days post transplant.

Countries

United States