Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN) (RENEW)

BioCryst

Status and phase: Terminated; Phase 2

Conditions: Immunoglobulin A Nephropathy; Membranous Nephropathy; Complement 3 Glomerulopathy

Treatments: Drug: BCX9930

Study type: Interventional

Funder types: Industry

Identifiers

NCT05162066

2020-005855-19 (EudraCT Number)

BCX9930-211

Details and patient eligibility

About

The objective of this study was to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body weight ≥ 40 kilograms (kg)
• Primary diagnosis of C3G, IgAN, or PMN confirmed by central pathology review
• An estimated glomerular filtration rate (eGFR) ≥ 50 milliter per minute per 1.73 meter square (mL/min/1.73 m^2) (or ≥ 30 mL/min/1.73 m^2 after Data Monitoring Committee [DMC] recommendation)
• Receiving treatment with a stable, maximum recommended or maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 60 days prior to the Day 1 Visit
• Documentation of current vaccinations against Neisseria meningitidis and Streptococcus pneumoniae or willingness to start vaccination series

Exclusion criteria

• Known congenital deficiency of C1s, C1r, C1q, C2, or C4
• History of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation
• Myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition
• History of malignancy within 5 years prior to the screening visit
• Active serious bacterial, viral, or fungal infection or any other serious infection within 14 days of screening
• Treatment with any systemic immunosuppressive or immunomodulatory therapy within 90 days OR anti-CD20 antibody therapies (eg, rituximab) within 180 days prior to the screening visit
• Treatment with renin inhibitors (eg, aliskiren) or sodium-glucose-cotransporter 2 (SGLT2) inhibitors within 60 days prior to Day 1

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 3 patient groups

C3G cohort

Experimental group

Description:

Approximately 14 eligible participants with C3G will be enrolled.

Treatment:

Drug: BCX9930

IgAN cohort

Experimental group

Description:

Approximately 14 eligible participants with IgAN will be enrolled.

Treatment:

Drug: BCX9930

PMN cohort

Experimental group

Description:

Approximately 14 eligible participants with PMN will be enrolled.

Treatment:

Drug: BCX9930