Study of SAL-0951 Compared to Recombinant Human Erythropoietin in Anemic Patients Receiving Maintenance Hemodialysis

NCT06720025 | Completed Phase 3

• 1 other identifier: SAL0951A302
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of SAL-0951 in Chinese patients undergoing maintenance hemodialysis with chronic kidney disease and anemia，who are receiving stable treatment with erythropoietic stimulants (ESAs).

Conditions

Anemia

Keywords

Anemia; Renal Insufficiency; Chronic Dialyses; Renal Dialyses; Renal Hemodialysis; Hematinic; Hematopoietic Agents; Erythropoiesis Stimulating Agents; Enarodustat; rHuEPO

Outcome Measures

Primary Outcomes (1)

• Difference in mean hemoglobin (Hb) level between arms during the evaluation period after treatment (non-inferiority margin: -10 g/L)

  Hb levels during the evaluation period after treatment are defined as the mean value of Hb levels at weeks 20, 22, and 24.

  weeks 20, 22, and 24

Study Arms (2)

SAL-0951 tablets

EXPERIMENTAL

initial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Drug: SAL-0951 tablets

rHuEPO injection

ACTIVE COMPARATOR

Initial based on the original rHuEPO dose adjust the dose based on hemoglobin concentration level every 4 weeks

Drug: rHuEPO injection

Interventions

SAL-0951 tablets DRUG

initial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Also known as: SAL-0951 group

SAL-0951 tablets

rHuEPO injection DRUG

Initial based on the original rHuEPO dose adjust the dose based on hemoglobin concentration level every 4 weeks

Also known as: rHuEPO group

rHuEPO injection

Eligibility Criteria

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

You may qualify if:

• Patients receiving hemodialysis (including hemodiafiltration) consistently three times a week for at least 12 weeks before Scr Visit 1.Dialysis is performed through autologous arteriovenous fistula or graft fistula (artificial blood vessel) or permanent tunnel catheter (central venous catheter with cuff).
• Patients with TSAT\*1 \>20% or ferritin \>75 μg/L at Scr Visit 1
• \*1: If serum iron values are invalid values, TSAT values shall also be handled as invalid values and re-test will be performed (For patients with ferritin \>75 μg/L, there is no need for re-test).
• Patients who have continued to receive the treatment with the same ESAs (rHuEPO or DA) for at least 4 weeks before Scr Visit 1
• Patients receiving ESAs for at least 2 weeks before Scr Visit 1 satisfying a) and c), or b) and c) below
• Patients receiving rHuEPO once to three times weekly, and at a total weekly dose of ≥750 IU and ≤9,000 IU
• Patients receiving DA once weekly, and at a dose of 10 µg, 20 μg or 30 μg
• Patients receiving ESAs at a constant total weekly dose for 2 weeks before Scr Visit 1
• Patients who have received the same ESAs as received in most recent week before Scr Visit 1 during the period between Scr Visit 1 and the day before Week 0 at the same total dose and dosing frequency a week\*1
• \*1: If ESAs is administered once weekly on the third dialysis day (Friday, if dialysis is performed, for instance, on Monday, Wednesday, and Friday), ESAs administration on the third dialysis day immediately before Week 0 will not be performed.
• Patients with pre-dialysis Hb levels measured after the maximum interdialytic interval at Scr Visit 1 and Scr Visit 2 (1 week after the start of observation) of ≥95 g/L and \<120 g/L and a difference (in absolute value) between Scr Visit 1 and Scr Visit 2 of ≤10 g/L
• Weight 45 to 100 kg

You may not qualify if:

• Patients with poorly controlled hypertension (e.g., systolic blood pressure ≥180 mmHg and diastolic blood pressure ≥110 mmHg at Scr Visit 1 and Scr Visit 2)
• Patients with severe hepatobiliary disease (e.g., AST or ALT \>2.5x upper limit of normal value at Scr Visit 1, hepatic cirrhosis, total bilirubin 1.5x upper limit of normal value at Scr Visit 1
• Patients with congestive heart failure (NYHA Class III or IV) or unstable angina
• Patients who have developed myocardial infarction, cerebral infarction (excluding asymptomatic cerebral infarction), or venous thromboembolism (pulmonary embolism or deep vein thrombosis or dialysis vascular pathway thrombosis or occlusion) during the period between 24 weeks before Scr Visit 1 and the registration to the treatment period
• Patients who will undergo an ophthalmological procedure (photocoagulation therapy or vitreous surgery) for the treatment of diabetic retinopathy, diabetic macular edema, or age- related macular degeneration during the period between Scr Visit 1 and the end of the study
• Patients who have undergone erythrocyte transfusion during the period between 12 weeks before Scr Visit 1 and the registration to the treatment period (according to clinical treatment indications, transfusions of blood products that do not contain red blood cells may be excluded, such as plasma, albumin, etc.)
• Patients who have received protein anabolic hormones, testosterone enanthate, or mepitiostane during the period between 12 weeks before Scr Visit 1 and the registration to the treatment period
• Patients with severe hyperparathyroidism (e.g., intact-PTH ≥500 pg/mL at Scr Visit 1)
• Patients with severe infections (such as active pulmonary tuberculosis, fungal infections, etc.), systemic hematological diseases (such as myelodysplastic syndrome, aplastic anemia, abnormal hemoglobin disease, etc.) or hemolytic anemia, or patients with anemia caused by bleeding disorders (such as gastrointestinal bleeding, etc.)
• Except for glomerulonephritis, anemia patients suspected to be caused by non infectious chronic inflammatory diseases such as systemic lupus erythematosus, rheumatoid arthritis, celiac disease, etc.
• Patients with malignancy (including hematological malignancy), except for tumors determined to be cured or in remission for 5 years, skin basal cell or squamous cell carcinoma that has undergone radical resection, or in situ carcinoma of any part
• Patients with a history of severe drug allergies, such as anaphylactic shock or allergies to rHuEPO or other HIF-PHI
• Patients with current or previous history of drug dependence or alcohol dependence within the past 2 years
• Patients who have received another investigational product (or study drug), have received treatment with an investigational device (or study device), or have participated in clinical research involving intervention (medical action beyond the scope of ordinary medical practice intended for research purposes) and received treatment during the period between 12 weeks before Scr Visit 1 and the registration to the treatment period
• Patients who have previously participated in a clinical study of SAL-0951 and received the investigational product (active drug)

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510062, China

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Wei Chen, Ph.D

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: September 19, 2023
• Primary Completion: June 17, 2024
• Study Completion: June 20, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)