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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN) (Phase 3 Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN))

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

Nakamine Kei

Alexion Pharma G.K.

3-1-1 Shibaura, Minato-ku, Tokyo 108-0023, Japan

JPDept-DevOps-PMCO@alexion.com

Nakamine Kei

Alexion Pharma G.K.

3-1-1 Shibaura, Minato-ku, Tokyo 108-0023, Japan

+81-3-3457-9559

JPDept-DevOps-PMCO@alexion.com

Recruiting

April. 12, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period for participants with eGFR >= 30 mL/min/1.73 m2.
2. For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsy is required within 6 months prior to Screening or during the Screening Period.
3. UPCR >= 0.75 g/g or UP >= 1 g/d calculated from the mean of two 24-hour urine during the Screening Period.
4. Estimated GFR >= 30 mL/min/1.73 m2 at Screening.
5. Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for >= 3 months prior to Screening with no planned change during Screening through Week 106.
6. Participants who are receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for >= 3 months prior to Screening with no planned change in dose through Week 106.

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. IgAV-N may be eligible).
3. Concomitant clinically significant renal disease other than IgAN
4. Prior use of immunosuppressive treatment within 3 months of screening.
5. Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%
6. Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of 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

Both

Participants with IgAN

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.

IgAN

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

Change from Baseline in Glomerular Filtration Rate (eGFR) at Week 106

+81-568-57-0057

Mar. 05, 2024

Yes

Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Argentina/Australia/Austria/Belgium/Brazil/Canada/Chile/China/Colombia/Czech Republic/France/Germany/Greece/Hong Kong/Hungary/Israel/Italy/Malaysia/Mexico/Netherlands/Poland/Saudi Arabia/Slovakia/South Korea/Spain/Taiwan/Thailand/Turkey/UK/USA