Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06137768
Other study ID # HRS-5965-201
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date January 2024
Est. completion date March 2025

Study information

Verified date November 2023
Source Chengdu Suncadia Medicine Co., Ltd.
Contact Sheng Qi
Phone +86 0518 82342973
Email Sheng.qi@hengrui.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 105
Est. completion date March 2025
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Able and willing to provide a written informed consent; 2. Weight =35 kg, Body mass index (BMI) < 37.5kg /m2; 3. Primary IgA nephropathy was confirmed by renal biopsy within 5 years; 4. 24-UPE= 0.75g /24h, or UPCR= 0.8g/g at screening and prior to randomization; 5. eGFR=30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula) 6. 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); 7. 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; Exclusion Criteria: 1. Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator; 2. Patients with secondary IgA nephropathy as determined by the investigator; 3. 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%; 4. Patients with a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; 5. Have any organ transplant; 6. 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; 7. Patients with a history of malignant neoplasms; 8. 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; 9. 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; 10. The presence of a disease or medical condition determined by the investigator might affect drug absorption, distribution, metabolism, and excretion; 11. As determined by the investigator, the subject has any of the following: progression or recovery of a disease; 12. Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or total bilirubin exceeding 3 times the upper limit of normal (ULN) at screening; 13. 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; 14. Women who are pregnant or breastfeeding; 15. A history of drug abuse; 16. Any physical or mental illness or condition that, as determined by the investigator, is likely to increase the risk of the study, affect the subject's adherence to the protocol, or prevent the subject from completing the study.

Study Design


Intervention

Drug:
HRS-5965
HRS-5965
Placebo
Placebo.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chengdu Suncadia Medicine Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline Baseline and Week 12
Secondary Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline Baseline and Week 24
Secondary Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline up to Week 24
Secondary Ratio of 24-hour Urinary protein excretion(UPE) to baseline up to Week 24
Secondary Change from baseline of estimated glomerular filtration rate(eGFR) up to Week 24
Secondary Change from baseline of serum creatinine up to Week 24
Secondary Ratio of Urinary protein to creatinine ratio and Urinary albumin to creatinine ratio to baseline up to Week 24
See also
  Status Clinical Trial Phase
Completed NCT03643965 - Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy Phase 3
Recruiting NCT04557462 - A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy Phase 3
Active, not recruiting NCT04541043 - Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE) Phase 3
Recruiting NCT05847920 - Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy Phase 2
Recruiting NCT02765594 - Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy Phase 4
Not yet recruiting NCT02712697 - Integrative Medicine of IgA Nephropathy N/A
Completed NCT04887532 - A Trial of HR19042 Capsule in Healthy Chinese Subjects Phase 1
Completed NCT02351752 - Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study Phase 4
Completed NCT04014335 - A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy Phase 2
Completed NCT01738035 - The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease Phase 2
Recruiting NCT05797610 - A Study to Evaluate the Efficacy and Safety of RO7434656 in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression Phase 3