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

Primary Purpose

Diabetic Kidney Disease, IgA Nephropathy

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Placebo of SC0062
SC0062 low dose
SC0062 medium dose
SC0062 high dose
Sponsored by
Biocity Biopharmaceutics Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Sign the informed consent voluntarily, and fully understand and comply with the relevant procedures of the test; 2. Age range from 18 to 70 years old (including the critical value), gender is not limited; 3. Patients with chronic kidney disease (CKD) stage G2~G3a with albuminuria, requirements: eGFR ≥ 45 mL/min/1.73m^2 and < 90mL/min/1.73m^2 at Screening based on the CKD-EPI equation.. Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks; If an SGLT2i is prescribed, the dose must be stable or only slight changes from 4 weeks prior before randomization to the end of treatment (per Investigator judgement) . 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 and < 1500 mg/g during at screening. Cohort 2: Biopsy-proven IgA nephropathy; Urine protein-creatinine ratio (UPCR) ≥0.5g/g and < 2.5 g/g at screening. 4. 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; 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; 5. All participants should follow protocol defined contraceptives procedures. Exclusion Criteria: Women who were pregnant or breastfeeding; A WOCBP who has a positive blood pregnancy test (within 72 hours) 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 within 3 months prior to randomization; Other causes of chronic kidney disease are also diagnosed; 5.1 Type diabetes or other specific types of diabetes; 6. Secondary IgA nephropathy; 7. Clinical suspicion of rapidly progressive glomerulonephritis (RPGN); 8. Diagnosed with nephrotic syndrome; 9. Have a history of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema, pulmonary edema, etc.); 10. Subjects who had received endothelin receptor antagonist in the past; 11. History of moderate or severe edema, non-traumatic facial edema, or myxoid edema within the 6 months prior to randomization; 12. History of orthostatic hypotension within 6 months prior to randomization; 13. History of clinically significant cirrhosis; 14. History of heart failure or previous hospital admissions due to fluid overload; 15. History of renal transplantation or other organ transplantation; 16. Hypothyroidism (except subclinical hypothyroidism or stable hypothyroidism after hormone replacement therapy); 17. 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; 18. 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; 19. Active hepatitis B; active hepatitis C; active syphilis; positive HIV serum reaction. 20. Malignancy within the past 5 years.; 21.Alcohol or drug abuse or dependence, or a history of psychological disorder; 22. Participants participated in clinical trials of other investigational drugs or medical devices within 3 months prior to randomization; 23. 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; 24. The investigator believes that the subject has any other reasons for not being eligible to participate in this clinical study.

Sites / Locations

  • 79 Qingchun Rd.,Shangcheng DistrictRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SC0062 low dose group

SC0062 medium dose group

SC0062 high dose group

Placebo of SC0062 group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change in urine albumin creatinine ratio (UACR) at Week 12
Change from baseline to Week12 in urine albumin creatinine ratio (UACR)
Changes in urine protein creatinine ratio (UPCR) at Week 12
Change from baseline to Week12 in urine protein creatinine ratio (UPCR)

Secondary Outcome Measures

Change in urine albumin creatinine ratio (UACR) by visit
Change in urine albumin creatinine ratio (UACR) after treatment
Change in urine protein creatinine ratio (UPCR) by visit
Change in urine protein creatinine ratio (UPCR) after treatment
Changes in glomerular filtration rate (eGFR)
Change in glomerular filtration rate (eGFR) from baseline to end of study
Change of 24-hour urine albumin excretion rate (UAER)
Change of 24-hour urine albumin excretion rate (UAER) at Week 12 and 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
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

Full Information

First Posted
January 9, 2023
Last Updated
July 24, 2023
Sponsor
Biocity Biopharmaceutics Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05687890
Brief Title
A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocity Biopharmaceutics Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease, IgA Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SC0062 low dose group
Arm Type
Experimental
Arm Description
Subjects will take two capsules daily for 24 weeks during the treatment period
Arm Title
SC0062 medium dose group
Arm Type
Experimental
Arm Description
Subjects will take two capsules daily for 24 weeks during the treatment period
Arm Title
SC0062 high dose group
Arm Type
Experimental
Arm Description
Subjects will take two capsules daily for 24 weeks during the treatment period
Arm Title
Placebo of SC0062 group
Arm Type
Placebo Comparator
Arm Description
Subjects will take two capsules daily for 24 weeks during the treatment period
Intervention Type
Drug
Intervention Name(s)
Placebo of SC0062
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
SC0062 low dose
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
SC0062 medium dose
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
SC0062 high dose
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in urine albumin creatinine ratio (UACR) at Week 12
Description
Change from baseline to Week12 in urine albumin creatinine ratio (UACR)
Time Frame
Week 12
Title
Changes in urine protein creatinine ratio (UPCR) at Week 12
Description
Change from baseline to Week12 in urine protein creatinine ratio (UPCR)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in urine albumin creatinine ratio (UACR) by visit
Description
Change in urine albumin creatinine ratio (UACR) after treatment
Time Frame
Week 2, week 4, week 8, week 12, week 16, week 20, week 24
Title
Change in urine protein creatinine ratio (UPCR) by visit
Description
Change in urine protein creatinine ratio (UPCR) after treatment
Time Frame
Week 2, week 4, week 8, week 12, week 16, week 20, week 24
Title
Changes in glomerular filtration rate (eGFR)
Description
Change in glomerular filtration rate (eGFR) from baseline to end of study
Time Frame
Week 2, week 4, week 8, week 12, week 16, week 20, week 24
Title
Change of 24-hour urine albumin excretion rate (UAER)
Description
Change of 24-hour urine albumin excretion rate (UAER) at Week 12 and Week 24
Time Frame
Week 12, week 24
Title
Percentage of subjects achieving UACR ≥30%, ≥40%, and ≥50% reduction from baseline
Description
Percentage of subjects achieving UACR ≥30%, ≥40%, and ≥50% reduction at Week 12 and Week 24
Time Frame
Week 12, week 24
Title
Percentage of subjects achieving UPCR ≥30%, ≥40%, and ≥50% reduction from baseline
Description
Percentage of subjects achieving UPCR ≥30%, ≥40%, and ≥50% reduction at Week 12 and Week 24
Time Frame
Week 12, week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Sign the informed consent voluntarily, and fully understand and comply with the relevant procedures of the test; 2. Age range from 18 to 70 years old (including the critical value), gender is not limited; 3. Patients with chronic kidney disease (CKD) stage G2~G3a with albuminuria, requirements: eGFR ≥ 45 mL/min/1.73m^2 and < 90mL/min/1.73m^2 at Screening based on the CKD-EPI equation.. Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks; If an SGLT2i is prescribed, the dose must be stable or only slight changes from 4 weeks prior before randomization to the end of treatment (per Investigator judgement) . 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 and < 1500 mg/g during at screening. Cohort 2: Biopsy-proven IgA nephropathy; Urine protein-creatinine ratio (UPCR) ≥0.5g/g and < 2.5 g/g at screening. 4. 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; 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; 5. All participants should follow protocol defined contraceptives procedures. Exclusion Criteria: Women who were pregnant or breastfeeding; A WOCBP who has a positive blood pregnancy test (within 72 hours) 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 within 3 months prior to randomization; Other causes of chronic kidney disease are also diagnosed; 5.1 Type diabetes or other specific types of diabetes; 6. Secondary IgA nephropathy; 7. Clinical suspicion of rapidly progressive glomerulonephritis (RPGN); 8. Diagnosed with nephrotic syndrome; 9. Have a history of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema, pulmonary edema, etc.); 10. Subjects who had received endothelin receptor antagonist in the past; 11. History of moderate or severe edema, non-traumatic facial edema, or myxoid edema within the 6 months prior to randomization; 12. History of orthostatic hypotension within 6 months prior to randomization; 13. History of clinically significant cirrhosis; 14. History of heart failure or previous hospital admissions due to fluid overload; 15. History of renal transplantation or other organ transplantation; 16. Hypothyroidism (except subclinical hypothyroidism or stable hypothyroidism after hormone replacement therapy); 17. 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; 18. 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; 19. Active hepatitis B; active hepatitis C; active syphilis; positive HIV serum reaction. 20. Malignancy within the past 5 years.; 21.Alcohol or drug abuse or dependence, or a history of psychological disorder; 22. Participants participated in clinical trials of other investigational drugs or medical devices within 3 months prior to randomization; 23. 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; 24. The investigator believes that the subject has any other reasons for not being eligible to participate in this clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianghua Chen, Prof
Phone
13905814085
Email
chenjianghua@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoying Du, Doc.
Phone
13588413101
Email
Zyyyrct2010@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianghua Chen, Prof
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
79 Qingchun Rd.,Shangcheng District
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianghua Chen, Prof.
Phone
13905814085
Email
chenjianghua@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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