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A study to determine if ravulizumab can help preserve kidney function in adults with immunoglobulin A nephropathy (IgAN)
EU CTIS ID: 2023-507851-31-00
What this study is testing
Interim Analysis-To evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria in adult participants with IgAN Final Analysis-To evaluate the efficacy of ravulizumab compared with placebo on change in eGFR in adult participants with IgAN
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be ≥ 18 years of age at the time of signing the informed consent
- 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
- 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 receiving SGLT2I, DEARA (eg, sparsentan), 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
You likely can't join if
- Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening
- Ongoing budesonide therapy or budesonide therapy within 6 months prior to Screening
- Biologic(s) for the treatment of IgAN ≤ 6 months prior to Screening
- Secondary IgAN (eg, due to SLE, cirrhosis, or celiac disease; IgAV-N may be eligible, see Exclusion Criterion 5).
- Traditional Chinese medicines and Chinese proprietary medicines with systemic immunosuppressive properties including but not limited to Tripterygium Wilfordii or Tripterygium Wilfordii-containing medicines 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
See the full eligibility criteria
Who can join
- Participant must be ≥ 18 years of age at the time of signing the informed consent
- 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
- 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 receiving SGLT2I, DEARA (eg, sparsentan), 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
- 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 for participants with eGFR ≥ 30 mL/min/1.73 m2 a. 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. Kidney biopsy report must demonstrate < 75% each of interstitial fibrosis, tubular atrophy, and glomerular sclerosis.
- UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine samples collected during the Screening Period
- Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening as calculated by the CKD-EPI formula (Section 8.2.3). a. Participants in the AdKD cohorts require eGFR 20 to 29 mL/min/1.73 m2 at Screening.
- Body weight ≥ 30 kg at Screening
What rules you out
- Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening
- Ongoing budesonide therapy or budesonide therapy within 6 months prior to Screening
- Biologic(s) for the treatment of IgAN ≤ 6 months prior to Screening
- Secondary IgAN (eg, due to SLE, cirrhosis, or celiac disease; IgAV-N may be eligible, see Exclusion Criterion 5).
- Traditional Chinese medicines and Chinese proprietary medicines with systemic immunosuppressive properties including but not limited to Tripterygium Wilfordii or Tripterygium Wilfordii-containing medicines 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 Day 1 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.
- History of Neisseria meningitidis infection
- Concomitant clinically significant renal disease other than IgAN.
- Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%
- Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening
- History of kidney transplant or planned kidney transplant during the Treatment Period. a. Participants listed for kidney transplant may be eligible for the AdKD cohorts
- 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
- Evidence of active hepatitis C infection −Positive HCV antibody: Participants with positive HCV antibody and negative HCV RNA test during the Screening Period (local or central laboratory) and absence of cirrhosis may be enrolled.
- 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 active hepatitis B infection −Positive HBsAg or −Positive core antibody (anti-HBc): participants with positive anti-HBc but negative HBsAg may be enrolled if the hepatitis B virus DNA test result is negative during the Screening Period (local or central lab)
- 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 or any other systemic immunosuppression within 3 months of Screening (except short course steroids [approximately 14 days] for non-IgAN treatment)
The study team makes the final eligibility decision.
Where it's taking place
- Saudi Arabia
- Chile
- Egypt
- Israel
- Korea, Republic of
- China
- Hong Kong
- Colombia
- Mexico
- Brazil
- Turkey
- United States
- Canada
- Argentina
- United Kingdom
- Thailand
- Japan
- Malaysia
- Australia
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saudi Arabia; Chile; Egypt; Israel; Korea, Republic of; China and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.