RUCONEST® as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03791476|
Recruitment Status : Recruiting
First Posted : January 2, 2019
Last Update Posted : December 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Kidney Failure||Drug: rhC1INH Other: Saline Solution||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Intervention versus placebo|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||June 21, 2019|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Placebo Comparator: Control Group
Intervention is saline solution placebo (0.9% Sodium Chloride IV to equal volume of investigational arm: intraoperatively, and then every 12 hours x 2 = total of 3 doses)
Other: Saline Solution
Intervention is rhC1INH 100 U/kg intraoperative followed by 50 U/kg every 12 hours x 2 = total of 3 doses (200 U/kg)
C1 esterase inhibitor
Other Name: ruconest
- Number of patients that do not meet DGF criteria based on creatinine levels following kidney transplantation from DCD donor who are treated with study drug compared to placebo [ Time Frame: over a 12 month period ]Incidence of delayed graft function in the first 7 days following kidney transplant as defined as the initiation of dialysis in the first 7-days post transplantation and functional DGF as defined as a failure of the serum creatinine to decrease by at least 10% daily on 3 successive days during the first week post transplantation.
- Incidence of adverse and serious adverse events will be assessed via descriptive statistics method [ Time Frame: over a 12 month period ]The feasibility of different statistical methods to analyze the incidence of adverse and serious adverse events
- Ascertain whether any unexpected toxicities will occur in this patient population according to the Common Toxicity Criteria for Adverse Events (CTCAE) patient population [ Time Frame: over a 12 month period ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Willingness of participation will be evaluated based on number of potential study candidates (approaches) compared to the number of candidates that enroll in the study likely response rates [ Time Frame: over a 12 month period ]Enrollment rate of eligible participants
- Tolerability following drug administration as measured by blood pressure [ Time Frame: over a 12 month period ]The ability and tolerability to administer the study drug 3 times with appropriate post administration by recording blood pressure in mmHg
- Tolerability following drug administration as measured by HR (heart rate) [ Time Frame: over a 12 month period ]The ability and tolerability to administer the study drug 3 times with appropriate pre and post administration by recording heart rate as beats per minute
- Tolerability following drug administration as measured by temperature [ Time Frame: over a 12 month period ]The ability and tolerability to administer the study drug 3 times with appropriate pre and post administration by recording temperature in degrees Fahrenheit
- Tolerability following drug administration as measured by respiratory rate [ Time Frame: over a 12 month period ]The ability and tolerability to administer the study drug 3 times with appropriate pre and post administration by recording the respiratory rate as breathes per minute
- Tolerability of drug administration as measured by urinary output [ Time Frame: over a 12 month period ]To assess tolerability, upon administration of the drug, amount of urinary output will be recorded in mL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791476
|Contact: Luis Fernandez, MDfirstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Luis Fernandez, MD 608-263-9903 email@example.com|
|Principal Investigator: Luis Fernandez, MD|
|Principal Investigator:||Luis Fernandez||University of Wisconsin, Madison|