Clinical Trials List
2024-03-15 - 2031-12-31
Phase III
Not yet recruiting1
Recruiting9
ICD-10N05.9
Unspecified nephritic syndrome with unspecified morphologic changes
ICD-10N06.9
Isolated proteinuria with unspecified morphologic lesion
ICD-10N07.9
Hereditary nephropathy, not elsewhere classified with unspecified morphologic lesions
ICD-10N15.9
Renal tubulo-interstitial disease, unspecified
ICD-9583.9
Nephritis and nephropathy, not specified as acute or chronic, with unspecified pathological lesion in kidney
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)
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Sponsor
Alexion Pharmaceuticals, Inc
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蔡尚峰 Division of Nephrology
- TUNG-MIN YU Division of Nephrology
- CHENG-HSU CHEN Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- WEN-CHIH CHIANG Division of Nephrology
- 潘思宇 Division of Nephrology
- FAN-CHI CHANG Division of Nephrology
- - - Division of Nephrology
- YU-HSIANG CHOU Division of Nephrology
- 黃道民 Division of Nephrology
- 陳怡婷 Division of Nephrology
- CHUN-FU LAI Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Guan-Hsing Chen 無
- 陳佳晉 Division of Nephrology
- Ya-Chung Tian 無
- Wen-Hung Huang 無
- 塗貽然 Division of Nephrology
- Cheng-Chia Lee 無
- 呂悅安 Division of Nephrology
- 鄭雅蓮 Division of Nephrology
- 吳欣旭 無
- 鄭昌錡 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- I-WEN WU
- Li-Yee Hong Division of Nephrology
- Cai-Mei Zheng Division of Nephrology
- 林冠宏
- 高芷華 Division of Nephrology
- Mei-Yi Wu
- 洪冠予
- Chia-Te Liao Division of Nephrology
- I-jen Chiu
- YUNG-HO HSU Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• Endpoint: Change from Baseline in proteinuria based on
24-hour UPCR at Week 34
• Population: Adult participants with IgAN
• Treatment conditions: Ravulizumab and placebo
• Handling of intercurrent events:
− Data collected after use of alternative IgAN therapy
will be censored and imputed using copy increments
from reference
− Data collected after treatment discontinuation will be
included as observed
− Data following death, kidney transplant, or dialysis
will be imputed using 10% of worst change values
• Population-level summary: Difference in log change from
Baseline in UPCR between treatment groups at Week 34
Inclution Criteria
Age
1. Subjects must be ≥ 18 years old at the time of signing the subject consent form.
Subject Type and Disease Characteristics
2. For participants with an eGFR ≥ 30 mL/min/1.73 m², a diagnostic record of IgAN based on kidney tissue sections obtained before or during the screening period (Section 8.1.5).
a. For participants in the AdKD group: eGFR 20 to 29 mL/min/1.73 m² at screening. Kidney sections must be performed within 6 months prior to screening or during the screening period. Kidney section reports must show interstitial fibrosis, tubular atrophy, and glomerular sclerosis < 75%, respectively.
3. Based on the average of two 24-hour urine sample collections during the screening period, showing UPCR ≥ 0.75 g/g or UP ≥ 1 g/day, as described in Section 8.2.1.
4. At screening, the estimated glomerular filtration rate (GFR) calculated using the Chronic Kidney Disease-Epidemiology Collaborative Study Group (CKD-EPI) formula must be ≥ 30 mL/min/1.73 m² (Section 8.2.3).
a. Participants in the AdkD cohort must have an eGFR of 20 to 29 mL/min/1.73 m² at screening.
Weight
5. Weight at screening ≥ 30 kg
Sexual Intercourse and Contraception/Barrier Requirements
6. Male or Female
7. Agreement to adhere to the contraceptive guidelines outlined in the trial protocol, as described in Section 10.5
Informed Consent
8. As described in Section 10.1.3, the ability to provide a signed participant consent form that includes adherence to the Participant Consent Form (ICF) and the requirements and limitations listed in this trial protocol.
9. Subjects who have previously received and are concurrently using IgAN therapy must have adhered to a stable and maximum permissible or tolerable dose of a RASI (ACEI and/or ARB) for ≥ 3 months prior to screening, with no plans for changes during the screening period up to week 106. Subjects who cannot tolerate RASI medications may be included (Section 6.9).
10. If a subject is currently receiving an SGLT2I, DEARA (e.g., sparsentan), MRA, or ERA, they must have been receiving a stable and maximum permissible or tolerable dose for ≥ 3 months prior to screening, with no plans for changes up to week 106 (Section 6.9).
11. Blood pressure must be controlled at < 140/90 mmHg at screening.
12. To reduce the risk of meningococcal infection, all subjects must have been vaccinated against meningococcal serogroups A, C, W, and Y (and serogroup B, if applicable) within 3 years prior to receiving the trial treatment on Day 1. If vaccination is administered within 2 weeks prior to Day 1, subjects will receive prophylactic antibiotics for at least 2 weeks following their initial meningococcal vaccination (Section 8.1.7).
Exclusion Criteria
Medical Conditions
1. Diagnosis of rapidly worsening glomerulonephritis based on an eGFR reduction of ≥ 50% within the 3 months prior to screening.
2. Secondary IgAN (e.g., caused by systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may qualify, see Exclusion Criterion 5).
3. Concurrent clinically significant kidney disease other than IgAN.
4. Uncontrolled diabetes mellitus with a glycated hemoglobin (HbA1c) > 8.5%.
5. Allergic purpura (IgA vasculitis) requiring continuous systemic immunosuppressive therapy within the 12 months prior to screening.
6. History of kidney transplantation or planned kidney transplantation during the treatment period.
a. Participants on the kidney transplant list may qualify for the AdKD group.
7. History of other solid organ (heart, lung, small intestine, pancreas, or liver) or bone marrow transplants; or planned transplantation during treatment or open-label Ravulizumab access, except for corneal transplantation.
8. Body mass index ≥ 38 kg/m2.
9. Splenectomy or functional asplenia.
10. History of meningococcal infection.
11. Known history of HIV infection based on HIV-1/HIV-2 testing data, or a positive HIV-1/HIV-2 antibody titer at screening.
12. Evidence of active hepatitis B infection:
* HBsAg positive or
* Core antibody (anti-HBc) positive: Participants who are anti-HBc positive but HBsAg negative.
13. If the hepatitis B virus DNA test result is negative during screening (local or central laboratory), inclusion is possible.
Evidence of active hepatitis C infection:
* HCV antibody positive: Participants who are HCV antibody positive and HCV RNA test negative (local or central laboratory) during screening and do not have cirrhosis may be included.
14. Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
15. Drug or alcohol abuse or dependence within 1 year prior to screening that would interfere with participation in the clinical trial.
16. History of malignant tumors within 5 years prior to screening, excluding non-melanoma skin cancer or cervical carcinoma in situ that has been treated and has no evidence of recurrence.
17. Hypersensitivity to any component of the test treatment, including hypersensitivity to rodent proteins.
Previous/Concomitant Therapies
18. Received systemic corticosteroid therapy or any other systemic immunosuppressant (except for short-term steroids [approximately 14 days] for non-IgAN treatment) within 3 months prior to screening (Section 6.9).
19. Continuing budesonide therapy or receiving budesonide therapy within 6 months prior to screening.
20. Received biologic therapy for IgAN within ≤ 6 months prior to screening.
21. Received traditional Chinese medicine or proprietary Chinese medicine with systemic immunosuppressive properties within 6 months prior to screening, including but not limited to Tripterygium wilfordii or drugs containing Tripterygium wilfordii for the treatment of IgAN (Section 6.9).
22. Currently receiving or having received complement inhibitors within 30 days or 5 half-lives prior to screening, whichever is longer.
Previous/Companion Clinical Trial Experience
23. Participation in another investigational drug or device trial within 30 days prior to Day 1 of the investigational treatment or within 5 half-lives of the investigational product (whichever is longer).
Other Exclusion Criteria
24. Pregnant, breastfeeding, or intending to conceive during the trial.
25. Unable to attend specific follow-up appointments during the trial or unable to meet logistical requirements for investigational treatment administration.
26. Subject is imprisoned or lawfully detained at the institution due to administrative or judicial order.
27. Subject is an employee of Alexion, AstraZeneca, or the institution/trial center, or an immediate family member of an employee.
The Estimated Number of Participants
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Taiwan
42 participants
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Global
470 participants
