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CompletedNCT06016036Updated Aug 13, 2024

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

A Phase 3 interventional study of SAL-0951 and Placebo in Renal Anemia in Non-dialysis Chronic Kidney Disease, sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Dec 2020, registered Aug 2023).
Phase
Phase 3
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Renal Anemia in Non-dialysis Chronic Kidney Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 156 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd. is the lead sponsor of 39 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18-75 years old men and women;
  2. 40-100 kg weight;
  3. 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;
  4. Ferritin > 100 g/L and TSAT > 20%;
  5. 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;
  6. The investigators determined that dialysis or alternative kidney transplantation was not required throughout the trial;
  7. Volunteer to participate in the trial and have an informed consent form signed.

Exclusion criteria

Exclusion Criteria:

  1. Blood pressure control was poor after regular drug therapy for more than 4 weeks before screening, SBP > 160mmHg or DBP > 100mmHg during screening;
  2. Patients with severe complications of hepatobiliary system (AST or ALT > 2.5 ULN, TBiL > 1.5 ULN);
  3. Acute kidney injury occurred 12 weeks before screening;
  4. NYHA class III - IV heart failure or unstable angina;
  5. Acute myocardial infarction, transient ischemic attack, cerebral infarction or pulmonary embolism, deep venous thrombosis occurred 6 months before randomization;
  6. Patients requiring ophthalmologic treatment for diabetic eye disease, diabetic macular edema, or age-related macular degeneration, or patients with hypertrophic choroid or retinopathy;
  7. Blood transfusion or red blood cell infusion within 3 months before screening;
  8. Subjects received protein anabolic hormone, testosterone heptanoate, or methadone within 3 month before screening
  9. Severe hyperparathyroidism (iPTH>=500pg/mL);
  10. Patients with HIV, HCV or Treponema pallidum antibody positive, or HBsAg positive with HBV DNA>=1000 U/mL;
  11. Severe active infection (active tuberculosis, fungal infection, etc.), systemic blood disease (myelodysplastic syndrome, aplastic anemia), or hemolytic anemia, or hemorrhagic anemia;
  12. 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;
  13. Chronic inflammatory disease other than glomerulonephritis that may affect red blood cell production, such as systemic lupus erythematosus, rheumatoid arthritis, celiac disease, etc.;
  14. A history of severe allergy to medications (e.g. anaphylactic shock) or allergy to other HIF-PH inhibitors;
  15. A history of drug or alcohol abuse in the past two years;
  16. 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;
  17. SAL-0951 products or other HIF-PH inhibitors were used before screening;
  18. Female during pregnancy or lactation;
  19. 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);
  20. Medical conditions that the investigators believe may pose a safety risk to subjects, or confuse efficacy or safety evaluations, or interfere with subject participation.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
156 participants (actual)

Study arms

  • Experimental
    SAL-0951

    Drug: SAL-0951

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSAL-0951

    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

  • DrugPlacebo

    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

06

What researchers measure

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

    Time frame: Baseline and week 7-9

Secondary outcomes

  1. 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

    Time frame: Baseline to week 9

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

    Time frame: Week 7-9

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

    Time frame: Week 9

  4. 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

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

    Time frame: Week 9

  6. Double-blind phase:Proportion of subjects receiving intravenous iron at week 9

    Time frame: Week 9

07

Study locations

1 site
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 519041, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06016036
Lead sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Aug 29, 2023
Start date
Dec 8, 2020
Primary completion
Oct 8, 2021
Completion
Feb 21, 2022
Last update
Aug 13, 2024

Study contacts

Xueqing Yu, Ph.D
principal investigator · Guangdong Provincial People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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