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

NCT06016036 | Completed Phase 3

• 1 other identifier: SAL0951A301
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Anemia in Non-dialysis Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Difference in mean Hb concentration levels from baseline at weeks 7-9

  Change From Baseline in mean Hb concentration levels at week 7-9

  Baseline and week 7-9

Secondary Outcomes (6)

• double-blind phase：The cumulative percentage of subjects who achieved Hb response at any time from treatment to week 9

  Baseline to week 9

• Double-blind phase：Proportion of subjects with average Hb level ≥100 g/L at week 7-9

  Week 7-9

• Double-blind phase：Proportion of average Hb concentration ≥100g/L and ≤120g/L in week 9

  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

  Week 9

• Double-blind phase：By week 9, the cumulative proportion of Hb > 130 g/L

  Week 9

Study Arms (2)

SAL-0951

EXPERIMENTAL

Drug: SAL-0951

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SAL-0951 DRUG

SAL-0951： 1. initial phase：4mg QD for 8 weeks 2. subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Also known as: SAL-0951 group

SAL-0951

Placebo DRUG

SAL-0951 placebo： 1. initial phase：4mg QD for 8 weeks 2. subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Also known as: Placebo phase

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years old men and women;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 519041, China

Location

Study Officials

• Xueqing Yu, Ph.D

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: December 8, 2020
• Primary Completion: October 8, 2021
• Study Completion: February 21, 2022
• Last Updated: August 13, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)