NCT06137768 is a Phase 2 clinical trial of HRS-5965 in Primary IgA Nephropathy, sponsored by Chengdu Suncadia Medicine Co., Ltd..

Who is sponsoring NCT06137768?

NCT06137768 is sponsored by Chengdu Suncadia Medicine Co., Ltd..

What drugs are being tested in NCT06137768?

Interventions in NCT06137768: HRS-5965, Placebo.

What condition does NCT06137768 study?

NCT06137768 studies Primary IgA Nephropathy.

Is NCT06137768 still recruiting?

NCT06137768 is currently active, enrolled. Last updated 30 April 2025.

Last reviewed 2025-04-30 · How we verify

NCT06137768

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial of HRS-5965 Tablets in Primary IgA Nephropathy

Active, enrolled Phase 2 Last updated 30 April 2025

What this trial tests

Phase 2 trial testing HRS-5965 in Primary IgA Nephropathy in 123 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 December 2023

Primary endpoint
1 December 2024

31 August 2025

Quick facts

Lead sponsor	Chengdu Suncadia Medicine Co., Ltd.
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	123
Start date	19 December 2023
Primary completion	1 December 2024
Estimated completion	31 August 2025
Sites	1 location across China

Drugs / interventions tested

HRS-5965 — full drug profile →
Placebo

Conditions studied

Primary IgA Nephropathy — all drugs for Primary IgA Nephropathy →

Sponsor

Chengdu Suncadia Medicine Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Primary IgA Nephropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Non-immunosuppressive treatment for IgA nephropathy.
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, et al · · 2024 · cited 20× · PMID 38299639 · DOI 10.1002/14651858.cd003962.pub3
Factor B as a therapeutic target for the treatment of complement-mediated diseases.
Kavanagh D, Barratt J, Schubart A, Webb NJA, et al · · 2025 · cited 10× · PMID 40028332 · DOI 10.3389/fimmu.2025.1537974
IgA Nephropathy: An Overview of the Clinical Trials.
Gholizadeh Ghozloujeh Z, Selvaskandan H, Wiegley N, Lerma E, et al · · 2025 · cited 3× · PMID 41050133 · DOI 10.1016/j.xkme.2025.101078
Advances in Complement-Targeted Therapy for IgA Nephropathy.
Lu M, Li G. · · 2026 · PMID 41608159 · DOI 10.1159/000550108
Complement-Mediated Kidney Diseases: Role of Alternative Pathway in Glomerular Inflammation.
Barratt J, Garred P, Lafayette RA, Zhang H, et al · · 2026 · PMID 41550519 · DOI 10.1016/j.ekir.2025.11.029

Verify or expand the search:

Other trials of HRS-5965

Trials testing the same drug.

NCT05505955 — Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency · Phase 1 · completed

Other recruiting trials for Primary IgA Nephropathy

Currently open trials in the same condition.

NCT05797610 — A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA · Phase 3 · recruiting
NCT04557462 — A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in P · Phase 3 · recruiting

Other Chengdu Suncadia Medicine Co., Ltd. trials

Trials by the same sponsor.

NCT07040787 — Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects · Phase 1 · completed
NCT07035665 — A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects · Phase 1 · completed
NCT06715943 — Efficacy and Safety of HRS-5965 in Patients With PNH Who Are Still Anemia After Anti-C5 Antibody Treatment · Phase 3 · completed
NCT06674915 — Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment · Phase 1 · completed
NCT06684041 — A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Sub · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06137768 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chengdu Suncadia Medicine Co., Ltd.
Last refreshed: 30 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06137768.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing