IgA Nephropathy (IgAN)Phase 3NCT06819826
A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria
A Phase 3 study testing SC0062 strength 10mg in people with IgA Nephropathy (IgAN), run by Biocity Biopharmaceutics Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- SC0062 strength 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2025to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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.
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- 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).
Who cannot join
- 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%;
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- 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);
- A condition which had the potential to interfere with oral drug absorption, such as subtotal gastrectomy, clinically severe gastrointestinal disorders, or certain types of bariatric surgery;
- Use of potent CYP3A4 inducers and potent CYP3A4 inhibitors within 2 weeks (14 days) before randomization;
- Received other treatment for IgA nephropathy within 28 days prior to randomization except as permitted by the protocol;
- Active Hepatitis B, active Hepatitis C, active syphilis and Hiv-positive ;
- A history of malignant tumors within 5 years, except for skin squamous cell carcinoma, colon polyp or in situ cervical cancer, thyroid papillary carcinoma;
- A history of alcohol or drug abuse or dependence, or a history of mental illness;
- Participated in clinical trials of other investigational drugs or medical devices within 3 months prior to randomization;
- Any other clinically significant disease, condition, or medical history that may interfere with subjects' safety, study evaluation, and/or study procedures at the discretion of the investigator;
- Any other reasons for not being suitable for participating in this clinical study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Yuexiu District, 510800
Yu Xueqing, Prof, 020-83827812, yuxueqing@gdph.org.cn
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SC0062 Capsule in Patients with IgA Nephropathy and Proteinuria (SUCCESS-1)
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)
- Being tested
- SC0062 strength 10mg, Placebo matched to SC0062
- Keywords
- Endothelin Type A Receptor Antagonist
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC0062 strength 10mgDrug
Subjects will take 20 mg once daily for 108 weeks during the treatment period.
Placebo matched to SC0062Drug
Subjects will take 20 mg once daily for 108 weeks during the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| SC0062 group | Experimental | Subjects will take two capsules daily and the background medication for 108 weeks during the treatment period Receives: 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 Receives: Drug: Placebo matched to SC0062 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 36 weeks
Secondary outcomes (2)
Change from baseline in estimated glomerular filtration rate (eGFR) at 108 weeks
Estimated glomerular filtration rate (eGFR) will be calculated based on the 2009 CKD-EPI equation.
Measured: Baseline, 108 weeks
The total slope of estimated glomerular filtration rate (eGFR) from baseline to 108 weeks
the total eGFR slope is defined as the mean rate of change in eGFR from baseline to 108 weeks
Measured: Each visit from baseline to 108 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start14 Feb 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocity Biopharmaceutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819826
- Sponsor's protocol ID
- SC0062-301
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SC0062 Capsule in Patients with IgA Nephropathy and Proteinuria (SUCCESS-1)
- ClinicalTrials.gov ID
- NCT06819826
- Acronym / sponsor ID
- SC0062-301
- Conditions
- IgA Nephropathy (IgAN)
- Keywords
- Endothelin Type A Receptor Antagonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Biocity Biopharmaceutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC0062 group | Experimental | Drug: SC0062 strength 10mgSubjects will take two capsules daily and the background medication for 108 weeks during the treatment period |
| Placebo group | Placebo comparator | Drug: Placebo matched to SC0062Subjects will take two capsules daily and the background medication for 108 weeks during the treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Laboratory tests shall meet the following criteria:
- 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).
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC0062 strength 10mgSubjects will take 20 mg once daily for 108 weeks during the treatment period. | Drug | SC0062 group |
| Placebo matched to SC0062Subjects will take 20 mg once daily for 108 weeks during the treatment period. | Drug | Placebo group |
Primary outcome
Change from baseline in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 36 weeks
Time frame: Baseline, 36 weeks
UPCR is measured from the 24-hour urine collection samples.
2 secondary outcomes
Change from baseline in estimated glomerular filtration rate (eGFR) at 108 weeks
Time frame: Baseline, 108 weeks
The total slope of estimated glomerular filtration rate (eGFR) from baseline to 108 weeks
Time frame: Each visit from baseline to 108 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SC0062 strength 10mg in people with IgA Nephropathy (IgAN), 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 15 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 17 Feb 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Xueqing, Prof (020-838-27812, yuxueqing@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 36 weeks (time frame: Baseline, 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2025.