BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy

Phase 2

Withdrawn

• Conditions: IMN; idiopathic membranous nephropathy; 10029149

• Registration Number: NL-OMON37265
• Lead Sponsor: GlaxoSmithKline BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

• Subjects between 18 and 75 years of age (inclusive) with active IMN (confirmed with biopsy in last 3 y; biopsy should be available for independent evaluation) and proteinuria >400 mg/mmol. See protocol page 30 for details.
• Capable of giving IC.
• Females of childbearing potential: adequate method of contraception. See protocol page 39-40 for details.

Exclusion Criteria

• Non-Idiopathic MN or other condition affecting the kidney. See protocol page 40 for details.
• Patients known to be negative for anti-PLA2R autoantibody.
• Severely reduced or deteriorating kidney function (eGFR< 40mL/min/1.73m2). See protocol page 40 for details.
• Uncontrolled hypertension (>150/90).
• Defined prior therapies. See protocol page 41-42 for details.
• Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of remission at week 104.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key: Incidence of progression of IMN/failure to respond, eGFR <15mL/min/1.73m2,<br /><br>dialysis or transplantation, adverse events.</p><br>