A Randomized pilot study to evaluate the safety and efficacy of Cinryze (C1-Esterase Inhibitor (human)) for the treatment of graft rejection in kidney transplant patients

Phase 1

• Conditions: Acute Antibody Mediated Rejection (AMR) in kidney transplant patients; MedDRA version: 14.1Level: PTClassification code 10044439Term: Transplant rejectionSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-000441-12-DE
• Lead Sponsor: VIROPHARMA Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-11
• Study Completion: 2013-06-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- age : 18 years or older
- weight : above or equal to 50 kg
- Identified Human Leukocyte Antigen (HLA) donor-specific antibody (DSA)
- Achievement of adequate function of kidney transplant, as determined by creatinine clearance above or equal to 40 ml/min, within the first 4 weeks post-transplant
- First qualifying AMR episode, within 12 months after transplant
- Able to receive first dose of study drug, within 72 hours after the qualifying renal allograft biopsy that was diagnostic for AMR
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

- have received a deceased donor kidney with any of the following characteristics (Banff classification >=2 for arteriosclerosis, interstitial fibrosis or tubular atrophy ; pediatric and bloc kidney transplant)
- Rapid onset of severe oliguric AMR
- Any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results
- Any infection that causes hemodynamic compromise
- History of abnormal bleeding, clotting or any coagulopathy
- History of allergic reaction to C1 esterase inhibitor or other blood products
- Participation in the active dosing phase of any other investigational drug study within 30 days prior to dosing with the study drug
- Pregnancy or breastfeeding
- Within 48 hours prior to dosing with study drug, white blood cell count < 0.5*10e9/l or > 20*10e9/l
- Within 48 hours prior to dosing with study drug, platelet count < 25*10e9/l or > 600*10e9/l
- Receipt of any of the following AMR agents, within one month prior to the first dose of study drug : Eculizumab, Ecallantide, Bortezomib, any C1 esterase inhibitor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified