NCT03791476

RUCONEST® as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function

A Phase I/II,Single Center,Randomized,Double-Blind,Placebo-Controlled Study to Evaluate the Feasibility of Using Human Recombinant C1 Inhibitor(RUCONEST®) as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function in Recipients of Kidneys From Donation After Cardio-Circulatory Death

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An unmet medical need exists for therapeutic regimens in transplantation that allow immediate postoperative graft function, thereby improving graft survival. Delayed graft function (DGF) after transplantation is the most common complication affecting kidney allographs in the immediate transplant period. The specific aim of this study is to evaluate the effect of recombinant human C1-inhibitor (rhC1INH), as a kidney recipient intra- and post operative treatment strategy to decrease systemic inflammation and decrease the incidence of DGF from donation after cardiac death donors (DCD).

Detailed description

This is a randomized, single-center double blinded study. The main objective of this study are to determine the ability of rhC1INH to reduce the incidence and severity of delayed graft function in comparison to placebo in recipients of kidneys after cardio-circulatory determination of death (DCD). This trial has specifically been designed to evaluate the protective effect of rhC1INH treatment in patients at high risk of developing DGF. The selection of potential donors to be part of this study will be limited to the population of DCD donors which have historically shown a risk of developing DGF ranging between 40-55%. Participation in each group will be randomly assigned. Treatment will be administered by an intra-operative infusion of placebo or rhC1INH (100 Units/kg) IV followed by twice a day infusion of 50 Units/Kg IV for the following 48 hours. A total of 20 subjects will be divided into 2 groups: Group 1: Control group: standard recipient management + placebo (0.9% Sodium Chloride IV to equal volume of investigational arm: intraoperatively, and then every 12 hours x 2 = total of 3 doses). treatment (n=10) Group 2: Standard recipient management + 100 U/kg intraoperative followed by 50 U/kg every 12 hours x 2 = total of 3 doses (200 U/kg). Max dose 8400 units for the initial dose and 4200 units maximum for the second and third doses.

Conditions

• Kidney Failure

Interventions

Type	Name	Description
DRUG	rhC1INH	C1 esterase inhibitor
OTHER	Saline Solution	saline solution

Timeline

• Start date: 2019-06-21
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2019-01-02
• Last updated: 2020-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study