RAINIER

JRCT ID: jRCT2041240119

Registered date:05/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: IgA nephropathy
• Date of first enrollment: 20/11/2024
• Target sample size: 40
• Countries of recruitment: Canada,Japan,Mexico,Japan,USA,Japan,Brazil,Japan,Colombia,Japan,UK,Japan,Turkey,Japan,Israel,Japan,Australia,Japan,China,Japan,Hong Kong,Japan,Taiwan,Japan,S Korea,Japan,KSA,Japan,Austria,Japan,Belgium,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Ireland,Japan,Italy,Japan,Croatia,Japan,Lithuania,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Spain,Japan,Sweden Hungary Estonia Latvia,Japan
• Study type: Interventional

Intervention(s)

Drug: Povetacicept
Povetacicept is administered by subcutaneous injection.

Drug: placebo
Placebo is matched to Povetacicept subcutaneous injection administration.

Outcome(s)

Primary Outcome

Change from baseline in 24-hour urine protein to creatinine ratio (uPCR) at Week 36
Total estimated glomerular filtration rate (eGFR) slope through Week 104

Secondary Outcome

Change from baseline in eGFR at Week 104
Time to kidney disease progression, defined as >=30% decline in eGFR, end stage kidney disease, or death from kidney failure through Week 104
Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue score at Week 104

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Only the main criteria are listed
1) Diagnosed IgAN, with biopsy confirmation within 10 years of screening
2) The arithmetic mean of proteinuria excretion >=1.0 g/day or 24-hour urine protein creatinine ratio (uPCR) >=0.75 g/g
3) Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73m^2
4) Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB) as per protocol specification
5) Other protocol defined Inclusion criteria may apply

Exclude criteria

Only the main criteria are listed
1) Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol
2) Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening
3) Other protocol defined Exclusion criteria may apply

Related Information

• Primary Sponsor: Ogino Mika
• Secondary ID(s): NCT06564142