A study to determine if ravulizumab can help preserve kidney function in adults with immunoglobulin A nephropathy (IgAN)

Phase 1

• Conditions: Immunoglobulin A Nephropathy (IgAN); Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-507851-31-00
• Lead Sponsor: Alexion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

Participant must be = 18 years of age at the time of signing the informed consent, Adherence to and compliance with 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. Participants with intolerance to RASI medications may be included, 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, Controlled blood pressure of < 140/90 mmHg at Screening, To reduce the risk of meningococcal infection (N meningitidis), all participants must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) within 3 years prior to study intervention on Day 1. If vaccination occurs < 2 weeks from Day 1, the participant will receive prophylactic antibiotics for at least 2 weeks after initial meningococcal vaccination, Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period, UPCR = 0.75 g/g or UP =1 g/day from the mean of two 24-hour urine collections during Screening, Estimated GFR = 30 mL/min/1.73 m2 at Screening as calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI). a. 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. Kidney biopsy report must demonstrate < 75% each of interstitial fibrosis, tubular atrophy, and glomerular sclerosis., 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, Body weight = 30 kg at Screening, Male or female, Agree to follow protocol-specified contraception guidance, Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria

Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss = 50% over a period of 3 months prior to Screening, History of Neisseria meningitidis infection, Known history of human immunodeficiency virus (HIV) infection as documented by HIV-1/HIV-2 testing or positive HIV-1/HIV-2 antibody titer at Screening., Evidence of hepatitis B (positive hepatitis surface antigen [HBsAg] or positive core antibody (anti-HBc) with negative surface antibody [anti-HBs]) or hepatitis C viral infection (HCV antibody positive, except for participants with documented successful treatment. If locally available, sustained virologic response should be documented or established at Screening)., Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization., Drug or alcohol abuse or dependence within 1 year prior to Screening that interferes with ability to participate in the clinical study., History of malignancy within 5 years of Screening, except for nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence., Hypersensitivity to any ingredient contained in the study intervention, including to murine proteins., Systemic corticosteroid therapy (eg, prednisone or prednisone equivalent) = 10 mg/day or any other systemic immunosuppression for the treatment of IgAN within 6 months of Screening (except short course steroids [approximately 14 days] for non-IgAN treatment), Ongoing budesonide therapy or budesonide therapy > 3 months duration within 6 months prior to Screening, Biologic(s) for the treatment of IgAN = 6 months prior to Screening, Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease)., Tripterygium Wilfordii for the treatment of IgAN within 6 months prior to Screening, Currently receiving or previously received a complement inhibitor within 30 days or 5 half-lives, whichever is longer, prior to Screening, Participation in another investigational drug or investigational device study within 30 days before Screening or within 5 half-lives of that investigational product, whichever is greater., Pregnant, breastfeeding, or intending to conceive during the study., Inability to travel to the clinic for specified visits during the study or fulfill the logistical requirements of study intervention administration, Participant is imprisoned or lawfully retained at an institution via administrative or judicial order., Participant is an employee or directly related to an employee of Alexion, AstraZeneca, or the institution/investigational site., Concomitant clinically significant renal disease other than IgAN., Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%, Clinically active Henoch-Schonlein purpura (IgA vasculitis) requiring ongoing systemic immunosuppressive therapy at Screening, History of kidney transplant or planned kidney transplant during the Treatment Period., History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period or open-label Exploratory Cohort, except for corneal transplant., Body mass index = 38 kg/m2., Splenectomy or functional asplenia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified