A Trial of HRS-5965 Tablets in Primary IgA Nephropathy

NCT06137768 | Active Not Recruiting Phase 2

• 1 other identifier: HRS-5965-201
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy, and safety of HRS-5965 tablets for primary IgA nephropathy. To explore the effective dosage of HRS-5965 tablets for primary IgA nephropathy.

Conditions

Primary IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline

  Baseline and Week 12

Secondary Outcomes (6)

• Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline

  Baseline and Week 24

• Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline

  up to Week 24

• Ratio of 24-hour Urinary protein excretion（UPE） to baseline

  up to Week 24

• Change from baseline of estimated glomerular filtration rate（eGFR）

  up to Week 24

• Change from baseline of serum creatinine

  up to Week 24

Study Arms (5)

Treatment group A: HRS-5965; high dose

EXPERIMENTAL

Drug: HRS-5965

Treatment group B: HRS-5965; medium dose

EXPERIMENTAL

Drug: HRS-5965

Treatment group C: HRS-5965; low dose

EXPERIMENTAL

Drug: HRS-5965

Treatment group D: Placebo.

PLACEBO COMPARATOR

Drug: Placebo

Treatment group E

EXPERIMENTAL

Drug: HRS-5965

Interventions

HRS-5965 DRUG

HRS-5965

Treatment group A: HRS-5965; high dose; Treatment group B: HRS-5965; medium dose; Treatment group C: HRS-5965; low dose; Treatment group E

Placebo DRUG

Placebo.

Treatment group D: Placebo.

Eligibility Criteria

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

You may qualify if:

• Able and willing to provide a written informed consent；
• Weight ≥35 kg, Body mass index (BMI) \< 37.5kg /m2;
• Primary IgA nephropathy was confirmed by renal biopsy within 5 years;
• UPE≥ 0.75g /24h, or UPCR≥ 0.8g/g at screening and prior to randomization;
• eGFR≥30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula)
• A fertile female subject or a male subject whose partner is a fertile female, who has not had a fertility, sperm/egg donation plan from the signing of the informed consent to 1 month after the last dose, and voluntarily takes effective contraceptive measures (including the partner);
• Receiving optimal supportive therapy including RAS blockers for 12 weeks and stabilizing the dose for at least 4 weeks after reaching the maximum recommended dose or the maximum tolerated dose prior to randomization;

You may not qualify if:

• Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
• Patients with secondary IgA nephropathy as determined by the investigator;
• IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
• Patients with a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria;
• Have any organ transplant;
• Patients with chronic recurrent infections within 1 year prior to screening, such as liver abscess and pyelonephritis; Or subjects with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization;
• Patients with a history of malignant neoplasms;
• Patients with a history of severe trauma or major surgery within 12 weeks prior to screening, or who plan to undergo surgery during the study period;
• Patients with a history of blood donation or a history of severe blood loss (≥400 mL blood loss) within 12 weeks prior to screening, or who have received blood transfusions within 12 weeks prior to screening;
• The presence of a disease or medical condition determined by the investigator might affect drug absorption, distribution, metabolism, and excretion;
• As determined by the investigator, the subject has any of the following: progression or recovery of a disease;
• Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or total bilirubin exceeding 3 times the upper limit of normal (ULN) at screening;
• Participants who have participated in a clinical trial of any drug or medical device within 12 weeks prior to randomization and are expected to have residual effects of the investigational treatment (as determined by the investigator), or who were within the follow-up period of a clinical study, or within 5 half-lives of the investigational drug, or within 30 days (whichever is older) before screening;
• Women who are pregnant or breastfeeding;
• A history of drug abuse;

Sponsors & Collaborators

• Chengdu Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Beijing University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (1)

• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

  PMID: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: December 19, 2023
• Primary Completion: December 1, 2024
• Study Completion: August 31, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-03

Locations

CN (1)