Phase 3 Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

JRCT ID: jRCT2041240015

Registered date:12/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Participants with IgAN
• Date of first enrollment: 10/04/2024
• Target sample size: 15
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Saudi Arabia,Japan,Slovakia,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,UK,Japan,USA,Japan
• Study type: Interventional

Intervention(s)

Experimental: Ravulizumab IV q8w
Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered every 8 weeks (q8w).

Participants in the exploratory group will receive open-label weight based loading dose on Day 1 followed by open label weight based maintenance dose on Day 15 and q8weeks after.

Placebo Comparator: Placebo IV q8w
Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w.

Outcome(s)

Primary Outcome

Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34

Glomerular Filtration Rate (eGFR) Over 106 Weeks

Key inclusion & exclusion criteria

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

Include criteria

1. Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period
2. UPCR >= 0.75 g/g or UP >= 1 g/d from the mean of two 24-hour urine collections during Screening
3. eGFR >= 30 mL/min/1.73 m2 at Screening
4. Exploratory Cohort eGFR 20-29 mL/min/1.73 m2 at Screening. A kidney biopsy is required within 6 months prior to Screening or during the Screening Period
5. Presence of hematuria as defined by a positive result on urine dipstick for blood or >= 5 red blood cells (RBCs)/high power field microscopy on urine sediment during or within 3 months of Screening.
6. Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for >= 3 months prior to Screening with no planned change during the Screening through Week 106
7. Participants who are on an SGLT2I, ERA, or MRA must be on a stable and maximum allowed or tolerated dose for >= 3 months prior to Screening with no planned change through Week 106

Exclude criteria

1. Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss >= 50% over a period of 3 months prior to Screening
2. Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease)
3. Concomitant clinically significant renal disease other than IgAN
4. Prior use of immunosuppressive treatment for IgAN within 6 months of screening
5. Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%
6. Clinically active Henoch-Schonlein purpura (IgA vasculitis) requiring ongoing systemic immunosuppressive therapy at Screening
7. History of kidney transplant or planned kidney transplant during the Treatment Period
8. Splenectomy or functional asplenia
9. History of Neisseria meningitidis infection
10. Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization

Related Information

• Primary Sponsor: Wuebbenhorst Hiroaki
• Secondary ID(s): NCT06291376