Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Immune System Diseases [C20]; MedDRA version: 20.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders; Immunoglobulin A (IgA) nephropathy

• Registration Number: EUCTR2017-004366-10-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-04
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 21

Inclusion Criteria

• Subjects with IgAN, aged between 18-75 years
• Biopsy proven IgAN, with an IgAN Oxford Classification Score of M1 and/or E1 and T0/1
• Clinically active disease, defined by proteinuria = 0.5 g/24h (PCR = 50 mg/mmol) on two separate occasions despite at least 3 months of maximized supportive therapy
• Female subjects not of child bearing potential, or of child bearing potential agreeing to use one of the contraceptive methods listed in the protocol

Other protocol defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• Secondary cause of IgAN, or renal impairment due to a condition that is not IgAN
• Severely reduced or deteriorating kidney function, defined by an eGFR < 30 ml/min at screening, or >15% decrease in eGFR in 3 months before screening
• Nephrotic syndrome
• Uncontrolled hypertension (>150/90 mmHg)
• Concomitant or recent immunosuppression
• Participation in another clinical trial of an investigational medicinal product (a minimum period of 1 year will be allowed between study completion of a biological investigational agent and commencement of this study, or 2 months for a non-biologic investigational agent)
• Use of traditional herbal medicines
• Prior use of biologic and/or cytotoxic therapies, and/or live vaccines within specified time periods
• Major organ transplant
• Malignant neoplasm within last 5 years
• Acute, chronic or recurrent infection
• Liver disease or abnormal liver function tests
• Significant unstable or uncontrolled co-morbid conditions
• Positive serology (HIV, Hepatitis B or C)
• History of primary immunodeficiency
• Significant IgG deficiency
• IgA deficiency
• Laboratory test abnormalities
• Drug sensitivity/anaphylaxis
• Drug or alcohol abuse or dependence
• Blood donation during the study period
• Serious suicide risk or suicidal ideation

Other protocol defined exclusion criteria may apply.

Study & Design

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