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

NCT06687174 | Not Yet Recruiting Phase 2

• 1 other identifier: MY008211A-IgAN-2-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and safety of MY008211A in IgAN patients

Conditions

IgA Nephropathy (IgAN)

Keywords

kidney disease; Primary glomerular disease

Outcome Measures

Primary Outcomes (1)

• The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12.

  Participants collected their urine over a 24-hour period.

  Week 12

Secondary Outcomes (6)

• The ratio of 24 h-UPCR relative to baseline at each visit during treatment period except Week 12.

  up to 24 weeks

• The ratio of 24-hour urine protein excretion (24 h-UPE) relative to baseline at each visit during treatment period.

  up to 24 weeks

• The ratio of 24-hour urine albumin (24 h-UA) relative to baseline at each visit during treatment period.

  up to 24 weeks

• The ratio of 24-hour urine albumin to creatinine concentration ratio (24 h-UACR) relative to baseline at each visit during treatment period.

  up to 24 weeks

• Change from baseline in serum creatinine at each visit during treatment period.

  up to 24 weeks

Study Arms (3)

MY008211A 200 mg BID

EXPERIMENTAL

200 mg taken twice a day.

Drug: MY008211A tablets

MY008211A 400 mg BID

EXPERIMENTAL

400 mg taken twice a day.

Drug: MY008211A tablets

Placebo

PLACEBO COMPARATOR

Matching placebo to MY008211A taken twice a day.

Drug: MY008211A tablets matched placebo

Interventions

MY008211A tablets DRUG

MY008211A BID

MY008211A 200 mg BID; MY008211A 400 mg BID

MY008211A tablets matched placebo DRUG

Matching placebo to MY008211A taken twice a day.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 18 and ≤ 75 years of age at Screening.
• Estimated GFR(eGFR) ≥30 mL/min/1.73m2.
• Subjects with a biopsy-confirmed diagnosis of IgAN.
• Urine protein ≥0.75 g/24h from a 24h urine collection.
• 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.
• 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.
• Vaccination against Neisseria meningitidis(MenACWY) is required within 3 years.
• Vaccination for the prevention of S. pneumoniae is required within 5 years.

You may not qualify if:

• Systolic blood pressure \>130 mm Hg or diastolic blood pressure \>80 mm Hg.
• Presence of any secondary IgAN.
• Presence of rapidly progressive glomerulonephritis.
• Presence of other chronic kidney diseases.
• Patients with a diagnosis of type 1 or type 2 diabetes mellitus.
• A history of invasive infections caused by encapsulated bacteria, e.g., meningococci or pneumococci.
• Patients previously treated with immunosuppressive agents exposure within 90 days prior to start of study drug dosing.
• Patients previously treated with traditional Chinese medicine containing immunosuppressive ingredients within 90 days prior to start of study drug dosing.
• Patients who had been treated with any systemic corticosteroids within the 180 days before treatment ≥20 mg/d for primary IgAN indication.
• 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).
• Patients who have received live/attenuated vaccines within the 4 weeks prior to randomization, or plan to receive during the trial.

Sponsors & Collaborators

• Wuhan Createrna Science and Technology Co., Ltd: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA; Kidney Diseases

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hong Zhang, PH.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donghui Li, PH.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The trial was a double-blind design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: December 31, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): January 31, 2028
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

CN (1)