A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney Disease

NCT05687890 | Active Not Recruiting Phase 2

• 1 other identifier: SC0062-202
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II study to investigate the safety, preliminary efficacy and pharmacokinetics of SC0062 capsule in patients with chronic kidney disease (diabetic kidney disease and IgA nephropathy)with albuminuria compared to matching placebo.

Conditions

Diabetic Kidney Disease; IgA Nephropathy

Outcome Measures

Primary Outcomes (2)

• Change in urine albumin creatinine ratio (UACR)

  Change from baseline at Week 12 in urine albumin creatinine ratio (UACR) in Cohort 1

  Week 12

• Changes in urine protein creatinine ratio (UPCR)

  Change from baseline at Week 12 in urine protein creatinine ratio (UPCR) in Cohort 2

  Week 12

Secondary Outcomes (7)

• Change in urine albumin creatinine ratio (UACR) by visit

  Week 2, week 4, week 8, week 12, week 16, week 20, week 24

• Change in urine protein creatinine ratio (UPCR) by visit

  Week 2, week 4, week 8, week 12, week 16, week 20, week 24

• Changes in glomerular filtration rate (eGFR)

  Week 2, week 4, week 8, week 12, week 16, week 20, week 24

• Change of 24-hour urine albumin excretion rate (UAER)

  Week 12, week 24

• Change of 24-hour urine protein excretion rate (UPER)

  Week 12, week 24

Study Arms (4)

SC0062 low dose group

EXPERIMENTAL

Subjects will take two capsules daily for 24 weeks during the treatment period

Drug: SC0062 low dose

SC0062 medium dose group

EXPERIMENTAL

Subjects will take two capsules daily for 24 weeks during the treatment period

Drug: Placebo of SC0062; Drug: SC0062 medium dose

SC0062 high dose group

EXPERIMENTAL

Subjects will take two capsules daily for 24 weeks during the treatment period

Drug: SC0062 high dose

Placebo of SC0062 group

PLACEBO COMPARATOR

Subjects will take two capsules daily for 24 weeks during the treatment period

Drug: Placebo of SC0062

Interventions

Placebo of SC0062 DRUG

Subjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period

Placebo of SC0062 group; SC0062 medium dose group

SC0062 low dose DRUG

Subjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period

SC0062 low dose group

SC0062 medium dose DRUG

Subjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period

SC0062 medium dose group

SC0062 high dose DRUG

Subjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period

SC0062 high dose group

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent voluntarily, and fully understand and comply with the relevant procedures of the test;
• Age of ≥ 18 years old, gender is not limited;
• Patients with chronic kidney disease (CKD) stage G1\~G3 with albuminuria, requirements:
• eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the CKD-EPI equation (2009).
• RAS inhibitor therapy (ACEi and/or ARB) has been administered for at least 12 weeks and the maximally tolerated dose has been stable for at least 4 weeks prior to randomization; If an SGLT2i is prescribed, the dose must be stable for at least 8 weeks prior to randomization.
• Cohort 1: Diagnosed with type 2 diabetes mellitus and receiving at least one hypoglycemic agent in the 12 months prior to randomization; In accordance with the diagnostic criteria of DKD, urine albumin to creatinine ratio (UACR) ≥300 mg/g before randomization.
• Cohort 2: Biopsy-proven IgA nephropathy; Urine protein-creatinine ratio (UPCR) ≥0.75 g/g or urine protein excretion rate ≥ 1.0 g/24h before randomization.
• Laboratory parameters meet the following criteria:
• Serum albumin ≥30 g/L;
• Hemoglobin value ≥90 g/L; Platelet ≥80×10\^9/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) ≤140 mmHg; Diastolic blood pressure (DBP) ≤90 mmHg;
• Hemoglobin A1c (HbA1c) ≤ 10% (cohort 1)/Hemoglobin A1c (HbA1c) \< 6.5% (cohort 2);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2×ULN; Total bilirubin ≤1.5ULN;

You may not qualify if:

• Women who were pregnant or breastfeeding; A WOCBP who has a positive blood pregnancy test prior to randomization;
• Patients who are allergic to or are allergic to any component of the study drug (SC0062 capsules);
• Systemic use of corticosteroids or immunosuppressants for more than 2 weeks within 3 months prior to randomization; with exceptions as follows: Topical or intra-articular, intranasal, and inhaled glucocorticoids; on stable doses of hydroxychloroquine for at least 8 weeks.
• Type 1 diabetes or other specific types of diabetes;
• Secondary IgA nephropathy;
• Clinical suspicion of rapidly progressive glomerulonephritis (RPGN);
• Diagnosed with nephrotic syndrome;
• Have a history of pulmonary hypertension (WHO Group 1), idiopathic pulmonary fibrosis or any lung disease requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema, pulmonary edema, etc.);
• Subjects who had received endothelin receptor antagonist in the past;
• History of moderate or severe edema, non-traumatic facial edema, or myxoid edema within the 6 months prior to randomization;
• History of orthostatic hypotension within 6 months prior to randomization;
• History of clinically significant cirrhosis;
• History of heart failure NYHA Class III\~IV; exacerbation heart failure or acute coronary syndrome within 6 months prior to randomization;
• History of renal transplantation or other organ transplantation;
• Hypothyroidism (except subclinical hypothyroidism or stable hypothyroidism after hormone replacement therapy);

Sponsors & Collaborators

• Biocity Biopharmaceutics Co., Ltd.: lead

Study Sites (1)

79 Qingchun Rd.,Shangcheng District

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (2)

• Heerspink HJL, Du X, Xu Y, Zhang Y, Liu B, Bi G, Xu C, Luo Q, Wu H, Wan J, Cao L, Wang R, Fan Q, Cheng H, Xu L, Huang J, Zhong A, Peng Q, Hei Y, Wang Y, Zhou B, Zhang L, Chen J. The Selective Endothelin Receptor Antagonist SC0062 in IgA Nephropathy: A Randomized Double-Blind Placebo-Controlled Clinical Trial. J Am Soc Nephrol. 2025 Apr 1;36(4):657-667. doi: 10.1681/ASN.0000000538. Epub 2024 Oct 26.

  PMID: 39462310 DERIVED

• 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

Diabetic Nephropathies; Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

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

Study Officials

• Jianghua Chen, Prof

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: May 23, 2023
• Primary Completion: November 30, 2024
• Study Completion: April 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-09

Locations

CN (1)