Refractory AMR in adult renal transplant participants MedDRA version: 20.0 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: Berinert 1500
Product Name: C1-INH [C1-esterase Inhibitor, Human (500 IU/mL)]
Product Code: C1-INH
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed
Sponsors
CSL Behring LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female at least 18 years of age; 2) Evidence of at least one donor-specific antibody (DSA); 3) Recipient of a kidney transplant; 4) Achieved a steady-state, post-transplant eGFR = 40 mL/min/1.73 m2 within 60 days of post-transplant OR a 50% increase in urine output with a 50% decrease in serum creatinine over the first 7 days posttransplant in subjects with slow or delayed graft function; 5) Acute AMR. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1) Recipient of an en bloc kidney transplant; 2) Current active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection ; 3) Active bacterial or fungal infection; 4) Ongoing dialysis >2 weeks; 5) Known congenital bleeding or coagulopathy disorder; 6) Current cancer or a history of cancer; 7) Female subjects who are pregnant or breast feeding; 8) Male or female subjects who are unwilling to use contraception or who are not surgically sterile.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of C1-INH in the treatment of refractory AMR in renal allograft recipients. ;Secondary Objective: The secondary objectives of the study are: 1. To evaluate the efficacy of C1-INH in the treatment of refractory AMR in renal allograft recipients. 2. To evaluate the safety of C1-INH in the treatment of refractory AMR in renal allograft recipients. 3. To evaluate the pharmacokinetics of C1-INH during the treatment of refractory AMR in renal allograft recipients. ;Primary end point(s): Time to loss of response during Treatment Period 2 ;Timepoint(s) of evaluation of this end point: Up to approximately 25 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to all-cause allograft failure through the follow-up period for both Treatment Period 1 responders and non-responders - Percentage of subjects with response to treatment at the end of Treatment Period 1 - Percentage of subjects with sustained improvement of eGFR during Treatment Period 2. - Change from screening in Banff category scores at up to 38 weeks - Percentage of subjects with splenectomy during Treatment Period 1 and during Treatment Period 2 - Percentage of subjects with allograft survival through the follow-up period - Time to subject death through the follow-up period - Percentage of subjects with any adverse event (AE) assessed as related to investigational product - Pre-dose C1-INH functional activity - Time to maximum plasma concentration (Cmax) for C1-INH functional activity - Area under the plasma concentration time curve (AUC0-t) for C1-INH functional activity;Timepoint(s) of evaluation of this end point: - Up to approximately 208 weeks - Up to approximately 13 weeks - Up to approximately 25 weeks - Screening and up to approximately 38 weeks - Up to approximately 38 weeks - Up to approximately 208 weeks - Up to approximately 208 weeks - Up to approximately 42 weeks after the time of first investigational product administration - Day 1, approximately Week 12, and approximately Week 38 - Up to 72 hours after dose - Up to 72 hours after dose | — |
Countries
Belgium, European Union, France, Germany, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactTrial Registration Coordinator
CSL Behring LLC
Outcome results
None listed