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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.
This multicenter, randomized, double blind, placebo parallel controlled, 2 cohorts phase II study will contain 2 cohorts:
Cohort 1: diabetic kidney disease
Cohort 2: biopsy-proven IgAN
In each cohort, approximately 120 patients will be randomized to receive SC0062 or placebo daily for 24 weeks.
The objective of this study is to evaluate the preliminary efficacy and safety of SC0062 capsules compared to placebo in patients with chronic kidney disease (diabetic kidney disease and IgA nephropathy) with albuminuria who are treated with the maximum tolerated labeled dose renin-angiotensin system inhibitor (RASi).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC0062 low dose group | Experimental | Subjects will take two capsules daily for 24 weeks during the treatment period |
|
| SC0062 medium dose group | Experimental | Subjects will take two capsules daily for 24 weeks during the treatment period |
|
| SC0062 high dose group | Experimental | Subjects will take two capsules daily for 24 weeks during the treatment period |
|
| Placebo of SC0062 group | Placebo Comparator | Subjects will take two capsules daily for 24 weeks during the treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in urine albumin creatinine ratio (UACR) by visit | Change in urine albumin creatinine ratio (UACR) after treatment | Week 2, week 4, week 8, week 12, week 16, week 20, week 24 |
| Change in urine protein creatinine ratio (UPCR) by visit |
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Inclusion Criteria:
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:
Laboratory parameters meet the following criteria:
All participants should follow protocol defined contraceptives procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianghua Chen, Prof | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 79 Qingchun Rd.,Shangcheng District | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39462310 | Derived | 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. | |
| 38299639 |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 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 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 |
|
Change in urine protein creatinine ratio (UPCR) after treatment
| Week 2, week 4, week 8, week 12, week 16, week 20, week 24 |
| Changes in glomerular filtration rate (eGFR) | Change in glomerular filtration rate (eGFR) from baseline to end of study | Week 2, week 4, week 8, week 12, week 16, week 20, week 24 |
| Change of 24-hour urine albumin excretion rate (UAER) | Change of 24-hour urine albumin excretion rate (UAER) at Week 12 and Week 24 in Cohort 1 | Week 12, week 24 |
| Change of 24-hour urine protein excretion rate (UPER) | Change of 24-hour urine protein excretion rate (UPER) at Week 12 and Week 24 in Cohort 2 | Week 12, week 24 |
| Percentage of subjects achieving UACR ≥30%, ≥40%, and ≥50% reduction from baseline | Percentage of subjects achieving UACR ≥30%, ≥40%, and ≥50% reduction at Week 12 and Week 24 in Cohort 1 | Week 12, week 24 |
| Percentage of subjects achieving UPCR ≥30%, ≥40%, and ≥50% reduction from baseline | Percentage of subjects achieving UPCR ≥30%, ≥40%, and ≥50% reduction at Week 12 and Week 24 in Cohort 2 | Week 12, week 24 |
| 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |