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SAL-0951 Tablets in the Treatment of Renal Anemia in Non-dialysis Chronic Kidney Disease

Primary Purpose

Renal Anemia in Non-dialysis Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SAL-0951
Placebo
Sponsored by
Shenzhen Salubris Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Anemia in Non-dialysis Chronic Kidney Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18-75 years old men and women; 40-100 kg weight; The glomerular filtration rate value calculated by CKD-EPI formula is <60 mL/min/1.73 m^2 (stage 3, 4 or 5 of KDOQI chronic kidney disease) in non-dialyzed subjects with confirmed anemia of chronic kidney disease; Ferritin > 100 g/L and TSAT > 20%; No treatment with ESA was received at least 8 weeks before randomization, and the central laboratory hemoglobin value for the last two screening period (at least 6 days interval) >=80 g/L and <=105 g/L, and the change of absolute value of the two visits <=10g/L; The investigators determined that dialysis or alternative kidney transplantation was not required throughout the trial; Volunteer to participate in the trial and have an informed consent form signed. Exclusion Criteria: Blood pressure control was poor after regular drug therapy for more than 4 weeks before screening, SBP > 160mmHg or DBP > 100mmHg during screening; Patients with severe complications of hepatobiliary system (AST or ALT > 2.5 ULN, TBiL > 1.5 ULN); Acute kidney injury occurred 12 weeks before screening; NYHA class III - IV heart failure or unstable angina; Acute myocardial infarction, transient ischemic attack, cerebral infarction or pulmonary embolism, deep venous thrombosis occurred 6 months before randomization; Patients requiring ophthalmologic treatment for diabetic eye disease, diabetic macular edema, or age-related macular degeneration, or patients with hypertrophic choroid or retinopathy; Blood transfusion or red blood cell infusion within 3 months before screening; Subjects received protein anabolic hormone, testosterone heptanoate, or methadone within 3 month before screening Severe hyperparathyroidism (iPTH>=500pg/mL); Patients with HIV, HCV or Treponema pallidum antibody positive, or HBsAg positive with HBV DNA>=1000 U/mL; Severe active infection (active tuberculosis, fungal infection, etc.), systemic blood disease (myelodysplastic syndrome, aplastic anemia), or hemolytic anemia, or hemorrhagic anemia; A history of malignancy, exceptions: tumors determined to be cured or in remission for 5 years, skin basal cell or squamous cell carcinomas that have been radically resected, or carcinomas in situ of any site; Chronic inflammatory disease other than glomerulonephritis that may affect red blood cell production, such as systemic lupus erythematosus, rheumatoid arthritis, celiac disease, etc.; A history of severe allergy to medications (e.g. anaphylactic shock) or allergy to other HIF-PH inhibitors; A history of drug or alcohol abuse in the past two years; Participated in clinical trials of any other drug or medical device within 3 months before screening, or plan to participate in any other clinical trials of drug or medical device during the trial; SAL-0951 products or other HIF-PH inhibitors were used before screening; Female during pregnancy or lactation; From the time the informed consent form was sighed to the end of the study, woman of childbearing age who does not agree to use effective contraception, or man whose sexual partner is a woman of childbearing age (Effective methods of contraception include transdermal patches, oral drugs, implantable or injectable contraceptives, abstinence or birth control); Medical conditions that the investigators believe may pose a safety risk to subjects, or confuse efficacy or safety evaluations, or interfere with subject participation.

Sites / Locations

  • Guangdong Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAL-0951

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Difference in mean Hb concentration levels from baseline at weeks 7-9
Change From Baseline in mean Hb concentration levels at week 7-9

Secondary Outcome Measures

double-blind phase:The cumulative percentage of subjects who achieved Hb response at any time from treatment to week 9
Change From Baseline in cumulative percentage of subjects who achieved Hb response at any time at week 9
Double-blind phase:Proportion of subjects with average Hb level ≥100 g/L at week 7-9
Double-blind phase:Proportion of average Hb concentration ≥100g/L and ≤120g/L in week 9
Double-blind phase:By week 9, the cumulative proportion of subjects whose Hb increased by ≥10 g/L and whose Hb reached ≥100g/L
Double-blind phase:By week 9, the cumulative proportion of Hb > 130 g/L
Double-blind phase:Proportion of subjects receiving intravenous iron at week 9

Full Information

First Posted
August 23, 2023
Last Updated
August 23, 2023
Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06016036
Brief Title
SAL-0951 Tablets in the Treatment of Renal Anemia in Non-dialysis Chronic Kidney Disease
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of SAL-0951 Tablets in the Treatment of Renal Anemia in Non-dialysis Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
February 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This study is a phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of SAL-0951 in CKD-anemia patients in Non-dialysis, comprising 8 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 27 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Anemia in Non-dialysis Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAL-0951
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SAL-0951
Other Intervention Name(s)
SAL-0951 group
Intervention Description
SAL-0951: initial phase:4mg QD for 8 weeks subsequent phase:1mg、2mg、4mg、6mg、8mg QD,adjust the dose based on hemoglobin concentration level every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo phase
Intervention Description
SAL-0951 placebo: initial phase:4mg QD for 8 weeks subsequent phase:1mg、2mg、4mg、6mg、8mg QD,adjust the dose based on hemoglobin concentration level every 4 weeks
Primary Outcome Measure Information:
Title
Difference in mean Hb concentration levels from baseline at weeks 7-9
Description
Change From Baseline in mean Hb concentration levels at week 7-9
Time Frame
Baseline and week 7-9
Secondary Outcome Measure Information:
Title
double-blind phase:The cumulative percentage of subjects who achieved Hb response at any time from treatment to week 9
Description
Change From Baseline in cumulative percentage of subjects who achieved Hb response at any time at week 9
Time Frame
Baseline to week 9
Title
Double-blind phase:Proportion of subjects with average Hb level ≥100 g/L at week 7-9
Time Frame
Week 7-9
Title
Double-blind phase:Proportion of average Hb concentration ≥100g/L and ≤120g/L in week 9
Time Frame
Week 9
Title
Double-blind phase:By week 9, the cumulative proportion of subjects whose Hb increased by ≥10 g/L and whose Hb reached ≥100g/L
Time Frame
Week 9
Title
Double-blind phase:By week 9, the cumulative proportion of Hb > 130 g/L
Time Frame
Week 9
Title
Double-blind phase:Proportion of subjects receiving intravenous iron at week 9
Time Frame
Week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-75 years old men and women; 40-100 kg weight; The glomerular filtration rate value calculated by CKD-EPI formula is <60 mL/min/1.73 m^2 (stage 3, 4 or 5 of KDOQI chronic kidney disease) in non-dialyzed subjects with confirmed anemia of chronic kidney disease; Ferritin > 100 g/L and TSAT > 20%; No treatment with ESA was received at least 8 weeks before randomization, and the central laboratory hemoglobin value for the last two screening period (at least 6 days interval) >=80 g/L and <=105 g/L, and the change of absolute value of the two visits <=10g/L; The investigators determined that dialysis or alternative kidney transplantation was not required throughout the trial; Volunteer to participate in the trial and have an informed consent form signed. Exclusion Criteria: Blood pressure control was poor after regular drug therapy for more than 4 weeks before screening, SBP > 160mmHg or DBP > 100mmHg during screening; Patients with severe complications of hepatobiliary system (AST or ALT > 2.5 ULN, TBiL > 1.5 ULN); Acute kidney injury occurred 12 weeks before screening; NYHA class III - IV heart failure or unstable angina; Acute myocardial infarction, transient ischemic attack, cerebral infarction or pulmonary embolism, deep venous thrombosis occurred 6 months before randomization; Patients requiring ophthalmologic treatment for diabetic eye disease, diabetic macular edema, or age-related macular degeneration, or patients with hypertrophic choroid or retinopathy; Blood transfusion or red blood cell infusion within 3 months before screening; Subjects received protein anabolic hormone, testosterone heptanoate, or methadone within 3 month before screening Severe hyperparathyroidism (iPTH>=500pg/mL); Patients with HIV, HCV or Treponema pallidum antibody positive, or HBsAg positive with HBV DNA>=1000 U/mL; Severe active infection (active tuberculosis, fungal infection, etc.), systemic blood disease (myelodysplastic syndrome, aplastic anemia), or hemolytic anemia, or hemorrhagic anemia; A history of malignancy, exceptions: tumors determined to be cured or in remission for 5 years, skin basal cell or squamous cell carcinomas that have been radically resected, or carcinomas in situ of any site; Chronic inflammatory disease other than glomerulonephritis that may affect red blood cell production, such as systemic lupus erythematosus, rheumatoid arthritis, celiac disease, etc.; A history of severe allergy to medications (e.g. anaphylactic shock) or allergy to other HIF-PH inhibitors; A history of drug or alcohol abuse in the past two years; Participated in clinical trials of any other drug or medical device within 3 months before screening, or plan to participate in any other clinical trials of drug or medical device during the trial; SAL-0951 products or other HIF-PH inhibitors were used before screening; Female during pregnancy or lactation; From the time the informed consent form was sighed to the end of the study, woman of childbearing age who does not agree to use effective contraception, or man whose sexual partner is a woman of childbearing age (Effective methods of contraception include transdermal patches, oral drugs, implantable or injectable contraceptives, abstinence or birth control); Medical conditions that the investigators believe may pose a safety risk to subjects, or confuse efficacy or safety evaluations, or interfere with subject participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueqing Yu, Ph.D
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
519041
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SAL-0951 Tablets in the Treatment of Renal Anemia in Non-dialysis Chronic Kidney Disease

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