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Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Primary IgA Nephropathy

NCT06982040•Nanjing Chia-tai Tianqing Pharmaceutical

View on ClinicalTrials.gov

Summary

NTQ5082 is a small molecule inhibitor of complement factor B (CFB) that inhibits the enzymatic activity of CFB, thereby blocking the alternative pathway of the complement activation cascade. It is being clinically developed for the treatment of primary IgA nephropathy The main objectives of the study were to assess the efficacy and safety of NTQ5082 capsules in the treatment of patients with primary IgA nephropathy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years, male or female.
•2. Body weight ≥40 kg, BMI between 15 to 38 kg/m².
•3. Diagnosis of primary IgA nephropathy confirmed by renal biopsy within 8 years before screening or during screening.
•4. 24-hour urine protein excretion (24h-UPE) ≥0.75 g/24h, or first morning void (FMV) urine protein-to-creatinine ratio (UPCR) ≥0.8 g/g.
•5. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m².
•6. Previously vaccinated with ACYW135 meningococcal polysaccharide vaccine and pneumococcal vaccine.
•7. Received renin-angiotensin system (RAS) inhibitor therapy for at least 12 weeks prior to randomization, with stable treatment at the maximum recommended dose or maximum tolerated dose of RAS inhibitors for at least 4 weeks prior to randomization.
•8. Agreement to use at least one effective contraceptive method with partners during sexual activity from signing the informed consent form until 4 weeks after the last administration of the investigational product, and refrain from sperm/egg donation during this period.

Exclusion Criteria

•1. Receipt of aldosterone receptor antagonists, renin inhibitors, or medications significantly affecting creatinine levels within 4 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
•2. Continuous use of systemic corticosteroids, immunosuppressants/modulators, or Chinese herbal medicines with immunosuppressive effects within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
•3. Treatment with biological agents or complement pathway inhibitors (other than the study drug) within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
•4. History of gastrointestinal surgery potentially altering drug absorption/distribution/metabolism/excretion, severe gastrointestinal disorders, or conditions causing dysphagia/recurrent vomiting that may interfere with oral medication intake.
•5. Major trauma/surgery within 12 weeks before screening or planned major surgery during the study.
•6. Previous bone marrow/hematopoietic stem cell transplantation or solid organ transplantation (e.g., heart, lung, kidney, liver).
•7. Known/suspected hereditary complement deficiency, or diagnosed primary/severe secondary immunodeficiency.
•8. Poorly controlled blood pressure as assessed by the investigator.
•9. Poorly controlled blood glucose as assessed by the investigator.
•10. Presence of nephrotic syndrome, rapidly progressive glomerulonephritis, renal pathology showing \>50% glomerular crescents, or \>50% tubular atrophy-interstitial fibrosis.
+2 more criteria

Key Dates

Start Date

May 1, 2025

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

May 21, 2025

Enrollment

ESTIMATED participants

Conditions

Primary IgA Nephropathy

Interventions

NTQ5082 capsules 100 mg

DRUG

NTQ5082 capsules 200 mg

DRUG

NTQ5082 capsules 300 mg

DRUG

Placebo

DRUG

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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: May 21, 2025Data 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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Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy

Replication of the NefIgArd Trial of TRF-budesonide in Primary IgAN

Integrative Medicine of IgA Nephropathy

Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study