CanaRIa (canakinumab in acute allograft rejection for regression of the infiltrate)

• Conditions: Acute cellular rejection after kidney transplantation; MedDRA version: 16.1Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-002825-52-DE
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-16
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1 Male or female patients aged at least 18 years at the time of study inclusion
2 Kidney transplant within the last 14 months
3 Evidence of acute cellular tubulointerstitial rejection in kidney transplant according to Banff criteria (grade IA or IB ), which has been detected in a protocol or indication biopsy, without evidence of more than 20 CD20-positive B cells per high power field in the infiltrate and without evidence glomerulitis or capillaritis
4 C4d and SV40 negativity in the biopsy
5 eGFR = 30 ml/min/1,73 m2 calculated by MDRD formula before diagnosis of rejection
6 In female patients of childbearing potential existence of a negative pregnancy test and consent to a highly effective method of contraception (Pearl Index < 1, i.e., hormonal implants, injectables, oral combination contraceptives, hormonal intrauterine devices, history of two-sided sterilization or oophorectomy, vasectomy of the partner, sexual abstinence, exclusively female sexual partners)
7 In male patients consent to a highly effective method of contraception (Pearl Index < 1, i.e., history of vasectomy, sexual abstinence, only male sexual partners; hormonal implants, injectables, oral combination contraceptives, hormonal intrauterine devices, history of sterilization or bilateral oophorectomy of the female partner with childbearing potential)
8 Written consent
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 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

1 Known contraindications or intolerance of canakinumab or concomitant medication
2 Administration of canakinumab within 14 months of study entry
3 Administration of another biologicals (eg, rituximab or basiliximab) or of a TNF-alpha blocker within the last 4 weeks prior to study entry
4 Simultaneous participation in another clinical trial
5 Body weight < 40 kg
6 Pregnant or lactating women
7 People who are not in a position to understand nature, significance and implications of the clinical study and to identify and align their will hereafter (pursuant to § 40 para 4 and § 41 para 2 and para 3 AMG)
8 Presence of CMV infection, HIV infection, replicative hepatitis B or hepatitis C, other serious infections, or a high risk for TB
9 Patients with previously known neutropenia (< 1.5/nl)
10 Heart failure NYHA stage III-IV
11 High-grade arrhythmias (eg ventricular tachycardia, symptomatic bradycardia , other hemodynamically significant arrhythmias )
12 Unstable coronary artery disease
13 History of splenectomy
14 Contraindication regarding a re-biopsy of the allograft (eg, coagulopathy, anticoagulation)
15 Presence of malignoma
16 Seronegativity (IgG) for EBV and VZV
17 Other exclusion criteria after assessment of the treating physician (eg, deterioration of general condition, derailed metabolic situation, high risk, such as AB0-incompatible kidney transplantation)

Study & Design

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