Renal Anemia in Non-dialysis Chronic Kidney DiseasePhase 3NCT06016036

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

A Phase 3 study testing SAL-0951 in people with Renal Anemia in Non-dialysis Chronic Kidney Disease, 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

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Renal Anemia in Non-dialysis Chronic Kidney Disease
What is being tested?: SAL-0951
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 156 participants
Where: 1 siteChina
Study dates: 8 Dec 2020to 21 Feb 2022
Phase: Phase 3

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

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 519041

Other trials in China

About this study

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

Conditions: Renal Anemia in Non-dialysis Chronic Kidney Disease
Being tested: SAL-0951, Placebo

What participants receive

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

SAL-0951Drug
Also called SAL-0951 group
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
PlaceboDrug
Also called Placebo phase
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

Study groups in NCT06016036
Study group	Role	What they receive
SAL-0951	Experimental	Not described Receives: Drug: SAL-0951
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Difference in mean Hb concentration levels from baseline at weeks 7-9
Change From Baseline in mean Hb concentration levels at week 7-9
Measured: 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
Change From Baseline in cumulative percentage of subjects who achieved Hb response at any time at week 9
Measured: Baseline to week 9
Double-blind phase：Proportion of subjects with average Hb level ≥100 g/L at week 7-9
Measured: Week 7-9
Double-blind phase：Proportion of average Hb concentration ≥100g/L and ≤120g/L in week 9
Measured: 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
Measured: Week 9
Double-blind phase：By week 9, the cumulative proportion of Hb > 130 g/L
Measured: Week 9
Double-blind phase：Proportion of subjects receiving intravenous iron at week 9
Measured: Week 9

Timeline

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

8 Dec 202021 Feb 2022

First posted29 Aug 2023
Study start8 Dec 2020
Primary completion8 Oct 2021
Study completion21 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal Anemia in Non-dialysis Chronic Kidney DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06016036
Sponsor's protocol ID: SAL0951A301
Status last verified: Aug 2023
First submitted: 23 Aug 2023
Last updated: 13 Aug 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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