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

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

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37265
Enrollment
6
Registered
2012-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IMN

Interventions

Treatment with belimumab or placebo.

Sponsors

GlaxoSmithKline BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 (eGFR150/90). • Defined prior therapies. See protocol page 41-42 for details. • Pregnancy or breastfeeding

Design outcomes

Primary

MeasureTime frame
Incidence of remission at week 104.—

Secondary

MeasureTime frame
Key: Incidence of progression of IMN/failure to respond, eGFR—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)