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AnemiaPhase 3NCT06720025

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

A Phase 3 study testing SAL-0951 tablets and rHuEPO injection in people with Anemia, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Anemia
What is being tested?
SAL-0951 tablets and rHuEPO injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
19 Sep 2023to 20 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.)
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  • 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)
  • Patients who are pregnant, lactating, or may be pregnant (the possibility of pregnancy cannot be ruled out by the PI or the SI based on the results of pregnancy test at Scr Visit 1
  • Female patients of childbearing potential who have not agreed to use appropriate contraception methods from the time of signing of informed consent to the end of the study, or male patients who have not agreed to use appropriate contraception methods*1 from the start of study treatment to the end of the study
  • 1 appropriate contraception methods Effective contraceptive methods include transdermal patches, oral medication, implantable or injectable contraceptives, abstinence or birth control surgery
  • Diagnosed as polycystic kidney disease
  • Positive for any of the following: human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or anti hepatitis C virus antibodies (anti HCV Ab), or confirmed syphilis requiring treatment
  • Received treatment with SAL-0951 or other HIF-PH inhibitors within the first 8 weeks of randomization
  • Any other medical condition that, in the opinion of the investigator, could pose a safety risk to the subject in this study, could confound efficacy or safety assessment, or could interfere with the subject's participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510062

Other trials in China

About this study

Official title: A Phase 3 Study to Compare the Efficacy and Safety of SAL-0951 With Recombinant Human Erythropoietin Injection in Anemic Patients With Chronic Kidney Disease Receiving Maintenance Hemodialysis <Switch / Maintenance Study>

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).

Read the detailed description

A randomized, open-label, rHuEPO positive-controlled, parallel-design multicenter clinical trial is used to evaluate the efficacy and safety of SAL-0951 in maintenance hemodialysis patients with anemia in CKD who were stable on ESAs. It is planned to enroll 100 subjects and eligible subjects screened are assigned 1:1 to the test arm and the control arm for a 24-week treatment to verify that the efficacy of SAL-0951 in the treatment of renal anemia in hemodialysis patients is non-inferior to that of rHuEPO and to verify the long-term safety of investigational drug in the treatment of renal anemia by comparing the difference in mean Hb levels between the two arms at weeks 20, 22, and 24 after treatment.

The study is mainly divided into four stages: screening period (2 weeks before administration), initial treatment period (4 weeks), maintenance treatment period (20 weeks), and safe follow-up period (2 weeks), requiring a total of 12 visits. This study included the 24th week visit as the end of treatment visit (EOT) and the 26th week as the end of study visit (EOS). Subjects who withdrew early are required to complete the research procedure for week 24.

Conditions
Anemia
Being tested
SAL-0951 tablets, rHuEPO injection
Keywords
Anemia, Renal Insufficiency, Chronic Dialyses, Renal Dialyses, Renal Hemodialysis, Hematinic, Hematopoietic Agents, Erythropoiesis Stimulating Agents, Enarodustat, rHuEPO
Medical subject headings
Anemia, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAL-0951 tabletsDrug

    Also called SAL-0951 group

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

  • rHuEPO injectionDrug

    Also called rHuEPO group

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

Study groups in NCT06720025
Study groupRoleWhat they receive
SAL-0951 tabletsExperimentalinitial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
Receives: Drug: SAL-0951 tablets
rHuEPO injectionActive comparatorInitial based on the original rHuEPO dose adjust the dose based on hemoglobin concentration level every 4 weeks
Receives: Drug: rHuEPO injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: weeks 20, 22, and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2024
  2. Study start19 Sep 2023
  3. Primary completion17 Jun 2024
  4. Study completion20 Jun 2024

Resources

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
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06720025
Sponsor's protocol ID
SAL0951A302
Status last verified
Nov 2024
First submitted
2 Dec 2024
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SAL-0951 tablets and rHuEPO injection in people with Anemia, run by Shenzhen Salubris Pharmaceuticals 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 12 inclusion and 22 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: finished, as of the sponsor's last update on 6 Dec 2024. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in mean hemoglobin (Hb) level between arms during the evaluation period after treatment (non-inferiority margin: -10 g/L) (time frame: weeks 20, 22, and 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06720025.

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 6 Dec 2024.

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