A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria

NCT06819826 | Recruiting Phase 3 DMC

• 1 other identifier: SC0062-301
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of SC0062 capsule compared to placebo in patients with IgA nephropathy in the presence of proteinuria. The participants must have a high risk of disease progression, despite of stable use of the maximum tolerated labelled or optimized dose of RAASi and/or SGLT2i for at least 12 weeks prior to randomization.

Conditions

IgA Nephropathy (IgAN)

Keywords

Endothelin Type A Receptor Antagonist

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 36 weeks

  UPCR is measured from the 24-hour urine collection samples.

  Baseline, 36 weeks

Secondary Outcomes (2)

• Change from baseline in estimated glomerular filtration rate (eGFR) at 108 weeks

  Baseline, 108 weeks

• The total slope of estimated glomerular filtration rate (eGFR) from baseline to 108 weeks

  Each visit from baseline to 108 weeks

Study Arms (2)

SC0062 group

EXPERIMENTAL

Subjects will take two capsules daily and the background medication for 108 weeks during the treatment period

Drug: SC0062 strength 10mg

Placebo group

PLACEBO COMPARATOR

Subjects will take two capsules daily and the background medication for 108 weeks during the treatment period

Drug: Placebo matched to SC0062

Interventions

SC0062 strength 10mg DRUG

Subjects will take 20 mg once daily for 108 weeks during the treatment period.

SC0062 group

Placebo matched to SC0062 DRUG

Subjects will take 20 mg once daily for 108 weeks during the treatment period.

Placebo group

Eligibility Criteria

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

You may qualify if:

• Voluntarily sign informed consent and fully understand and comply with trial procedures;
• Age ≥18 years old, gender unlimited;
• IgA nephropathy patients with proteinuria must meet all of the following conditions:
• According to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI, 2009) creatinine equation, after 12 weeks of the stable use of the background therapy, the mean of two estimated glomerular filtration rates (eGFR) calculated from central laboratory results was ≥ 30 and \< 90 mL/min/1.73m2.
• Received the maximum labeled or tolerated dose of RAASi (ACEI or ARB) for at least 12 weeks before randomization; If subjects were treated with SGLT2i, MRA, or GLP-1RA prior to randomization, the stable use was also required for at least 12 weeks (maximum tolerated and optimal dose determined by the investigator; Subjects who are intolerant to RAASi may also be enrolled).
• The pathological examination confirmed IgA nephropathy. Two 24-hour urine samples were collected during the screening period, after 12 weeks of the stable use of the background treatment. Both of the results conducted by the central laboratory were met: 24-hour urine protein to creatinine ratio (UPCR) ≥ 0.75 g/g or 24-hour urinary protein excretion rate (UPER) ≥ 1.0 g.
• Laboratory tests shall meet the following criteria:
• Serum albumin ≥ 30 g/L;
• Hemoglobin ≥ 90 g/L ; Platelet count ≥80×109/L;
• Brain natriuretic peptide (BNP) ≤ 200 pg/mL or N-terminal pro B-type natriuretic peptide (NT-proBNP) ≤ 600 pg/mL;
• Blood potassium ≤ 5.5 mmol/L;
• Systolic blood pressure (SBP) ≤ 160 mmHg;
• Hemoglobin A1c ≤ 8%;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2×ULN; Total bilirubin ≤ 1.5×ULN;
• During the entire study period from the signing of the informed consent to 3 months after the final administration, fertile females and males who have not received vasectomy should take effective contraceptive measures \[Effective contraceptive measures include: Vasectomy, intrauterine device (IUD), hormones (oral, patch, ring, injection, implant) and barrier methods (diaphragm, cervical cap, sponge, condom).

You may not qualify if:

• Pregnant or lactating females; Women of childbearing potential (WOCBP) who have a positive blood pregnancy test before randomization;
• A history of hypersensitivity or allergic to any component of the study drug (SC0062 capsule);
• Systemic use of corticosteroids or immunosuppressants for more than 2 weeks within 3 months prior to randomization; The following are excluded: local topical or intraarticular, intranasal and inhaled glucocorticoids; Use of biological agents (such as rituximab, Telitacicept, etc.), Iptacopan capsules, budesonide enteric-coated capsules within 6 months prior to randomization;
• Concurrent diagnosis of chronic kidney disease caused by other etiologies (including polycystic kidney disease, diabetic kidney disease, or other primary glomerular disease) as determined by the investigator;
• Secondary IgA nephropathy, including but not limited to: Henoch-Schönlein purpura, ankylosing spondylitis, systemic lupus erythematosus, amyloidosis, etc.
• Renal biopsy results showed that \> 25% of glomeruli with crescents, or interstitial fibrosis/tubular atrophy \> 50%;
• Based on KDIGO guidelines, rapidly progressive glomerulonephritis was clinically suspected (judged by the investigator);
• Nephrotic syndrome (UPER \> 3.5g/d and serum albumin \< 30g/L, with or without edema and hyperlipidemia) at screening;
• A history of any lung disease requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema, pulmonary edema, etc.);
• Use of the same class drug (endothelin receptor antagonist, ERA) before randomization;
• A history of moderate or severe edema, non-traumatic facial edema, or myxedema within the 6 months prior to randomization;
• A history of orthostatic hypotension within 6 months before randomization;
• A history of clinically significant cirrhosis assessed by the investigator;
• A history of worsening heart failure, acute coronary syndrome, transient ischemic attack, stroke and other serious cardiovascular and cerebrovascular diseases within 6 months prior to randomization, or NYHA Grade III to IV at screening;
• A history of kidney or other organ transplantation (except corneal transplantation);

Sponsors & Collaborators

• Biocity Biopharmaceutics Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Yuexiu District, 510800, China

RECRUITING

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

Central Study Contacts

Yu Xueqing, Prof

CONTACT

020-838-27812; yuxueqing@gdph.org.cn

Ye Zhiming, Prof

CONTACT

86+13826161678; Yezhiming@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: January 31, 2025
• First Posted: February 11, 2025
• Study Start: February 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 17, 2025

Record last verified: 2025-01

Locations

CN (1)