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Diabetic Kidney DiseasePhase 2NCT05687890

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

A Phase 2 study testing SC0062 low dose, SC0062 medium dose and SC0062 high dose in people with Diabetic Kidney Disease and IgA Nephropathy, run by Biocity Biopharmaceutics Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Kidney Disease, IgA Nephropathy
What is being tested?
SC0062 low dose, SC0062 medium dose and SC0062 high dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
255 participants
Where
1 siteChina
Study dates
23 May 2023to Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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;
  • All participants should follow protocol defined contraceptives procedures.

Who cannot join

  • 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);
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  • 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);
  • Patients who have the potential to interfere with oral drug absorption, such as subtotal gastrectomy, clinically severe gastrointestinal disease, or certain types of bariatric surgery, such as gastric bypass surgery, that do not involve simply separating the stomach into a separate chamber, such as gastric banding surgery;
  • Use of potent CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's Burt) and potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, voriconazole, clarithromycin, telomycin, nefazodone, ritonavir, saquinavir) within 1 month before randomization;
  • Active hepatitis B; active hepatitis C; active syphilis; positive HIV serum reaction.
  • Malignancy within the past 5 years (Except for treated basal cell carcinoma of the skin, effectively resected squamous cell carcinoma of the skin, colon polyps, or cervical cancer in situ that do not require ongoing treatment);
  • Alcohol or drug abuse or dependence, or a history of psychological disorder;
  • Participants participated in clinical trials of other investigational drugs or medical devices within 3 months prior to randomization;
  • Any other clinically significant clinical condition, or medical history may interfere with the subject's safety, study evaluation, and/or study procedures per the judgment by the investigator;
  • The investigator believes that the subject has any other reasons for not being eligible to participate in this clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • 79 Qingchun Rd.,Shangcheng District

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: A Randomized, Double Blind, Placebo Parallel Controlled, 2 Cohorts, Multicenter Phase II Study to Investigate the Safety and Efficacy of SC0062 Capsule in Patients With Chronic Kidney Disease With Albuminuria

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.

Read the detailed description

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).

Being tested
Placebo of SC0062, SC0062 low dose, SC0062 medium dose, SC0062 high dose
Medical subject headings
Diabetic Nephropathies, Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo of SC0062Drug

    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 doseDrug

    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 doseDrug

    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 doseDrug

    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

Study groups in NCT05687890
Study groupRoleWhat they receive
SC0062 low dose groupExperimentalSubjects will take two capsules daily for 24 weeks during the treatment period
Receives: Drug: SC0062 low dose
SC0062 medium dose groupExperimentalSubjects will take two capsules daily for 24 weeks during the treatment period
Receives: Drug: Placebo of SC0062; Drug: SC0062 medium dose
SC0062 high dose groupExperimentalSubjects will take two capsules daily for 24 weeks during the treatment period
Receives: Drug: SC0062 high dose
Placebo of SC0062 groupPlacebo comparatorSubjects will take two capsules daily for 24 weeks during the treatment period
Receives: Drug: Placebo of SC0062

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in urine albumin creatinine ratio (UACR)

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

    Measured: Week 12

  2. Changes in urine protein creatinine ratio (UPCR)

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

    Measured: Week 12

Secondary outcomes (7)

  1. Change in urine albumin creatinine ratio (UACR) by visit

    Change in urine albumin creatinine ratio (UACR) after treatment

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

  2. Change in urine protein creatinine ratio (UPCR) by visit

    Change in urine protein creatinine ratio (UPCR) after treatment

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

  3. Changes in glomerular filtration rate (eGFR)

    Change in glomerular filtration rate (eGFR) from baseline to end of study

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

  4. 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

    Measured: Week 12, week 24

  5. 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

    Measured: Week 12, week 24

  6. 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

    Measured: Week 12, week 24

  7. 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

    Measured: Week 12, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start23 May 2023
  3. Primary completion30 Nov 2024
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05687890
Sponsor's protocol ID
SC0062-202
Status last verified
Sep 2024
First submitted
9 Jan 2023
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Howie AJ, Lalayiannis AD. The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON. Kidney360. 2026 Oct 1;7(10):2382-2384. doi: 10.34067/KID.0000001083. Epub 2026 Feb 9. No abstract available.

    PubMed 41661687

  • 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.

    PubMed 39462310

  • 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.

    PubMed 38299639

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SC0062 low dose, SC0062 medium dose and SC0062 high dose in people with Diabetic Kidney Disease and IgA Nephropathy, run by Biocity Biopharmaceutics Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in urine albumin creatinine ratio (UACR) (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05687890, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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