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Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN) | Clinical Trials | Clareo Health

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Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

NCT06687174•Wuhan Createrna Science and Technology Co., Ltd

View on ClinicalTrials.gov

Summary

Efficacy and safety of MY008211A in IgAN patients

Detailed Description

This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study. Two doses of MY008211A (200mg, 400mg) were compared with placebo. The study comprised a screening period of this study for 90 days, an efficacy observation period for 24 weeks, a long-term study for 80 weeks, and a follow-up period for 2 weeks.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females ≥ 18 and ≤ 75 years of age at Screening.
•2. Estimated GFR(eGFR) ≥30 mL/min/1.73m2.
•3. Subjects with a biopsy-confirmed diagnosis of IgAN.
•4. Urine protein ≥0.75 g/24h from a 24h urine collection.
•5. All patients must have been on stable supportive care including a maximally tolerated dose or approved maximal dose of ACEi or ARB therapy for at least 90 days prior to the first administration of study drug.
•6. Subjects who received SGLT2i must have been on a stable treatment with the maximum allowed or tolerated dose prior to the first administration of study drug.
•7. Vaccination against Neisseria meningitidis(MenACWY) is required within 3 years.
•8. Vaccination for the prevention of S. pneumoniae is required within 5 years.

Exclusion Criteria

•1. Systolic blood pressure \>130 mm Hg or diastolic blood pressure \>80 mm Hg.
•2. Presence of any secondary IgAN.
•3. Presence of rapidly progressive glomerulonephritis.
•4. Presence of other chronic kidney diseases.
•5. Patients with a diagnosis of type 1 or type 2 diabetes mellitus.
•6. A history of invasive infections caused by encapsulated bacteria, e.g., meningococci or pneumococci.
•7. Patients previously treated with immunosuppressive agents exposure within 90 days prior to start of study drug dosing.
•8. Patients previously treated with traditional Chinese medicine containing immunosuppressive ingredients within 90 days prior to start of study drug dosing.
•9. Patients who had been treated with any systemic corticosteroids within the 180 days before treatment ≥20 mg/d for primary IgAN indication.
•10. Patients who previously have received biologic agent or monoclonal antibodies prior to start of study drug dosing within 5 half-lives or 30 days (whichever is longer).
+1 more criteria

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 31, 2024

Primary Completion Date

June 15, 2026

Completion Date

January 31, 2028

Last Updated

November 18, 2024

Enrollment

ESTIMATED participants

Conditions

IgA Nephropathy (IgAN)

Interventions

MY008211A tablets

DRUG

MY008211A tablets matched placebo

DRUG

Contacts

Donghui Li, PH.D.

CONTACT

(+86)027-68788900 lidonghui@createrna.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

Inclusion Criteria

Exclusion Criteria

A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

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