Safety, Tolerability and Efficacy of an antibody, which blocks the pro-inflammatory mediator Interleukin-6, in patients with late Antibody-mediated rejection of a transplanted kidney - A Pilot Trial

Phase 1

• Conditions: Antibody-mediated rejection of a kidney transplant; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-001604-30-DE
• Lead Sponsor: Charité Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-06
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

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

Inclusion Criteria

- Voluntary written informed consent
- Age >18 years
- functioning living or deceased donor allograft >365 days post-transplantation
- eGFR>30ml/min/1.73m2
- Detection of HLA class I and/or II antigen-specific antibodies (preformed and/or de novo DSA)
- Acute/active or chronic/active ABMR (±C4d in PTC) according to BANFF 2013/2015
- Molecular ABMR score (ABMRpm) =0.2
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- active participation in another clinical trial
- age <18 years
- female subject is pregnant or lactating
- index biopsy results:
*T-cell medated rejection classified BANFF grade = I
*de novo or recurrent severe thrombotic microangiopathy
*Polyoma virus nephropathy
* de novo or recurrrent glomerulonephritis
- acute rejection treatment <3 months before screening
- acute deterioration of graft function (eGFR decline within 1-3 months >25%)
- nephrotic range proteinuria >3500mg/g protein/creatinine ratio
- Active vrial, bacterial or fungal infection precluding intensified immunosuppression
- Active malignant disease precluding intensified immunosuppression
- Abnormal liver function tests (ALT, AST, bilirubin >1.5x upper limit of normal)
- Other significant liver disease
- latent or active tuberculosis (positive QuantiFERON- TB GOD test, Chest X-Ray)
- Administration of a live vaccine within 6 weeks of screening
- neutropenia (<1 G/L) or thrombocytopenia (<100 G/L)
- history of gastrointestinal perforation, diverticulitis, or inflammatory bowel disease
- history of alcohol or illicit substance abuse
- serious medical or psychiatric illness likely to interfere with participation in the study

Study & Design

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