Phase II Dose-Finding of Oral SSS17 for Anemia in Non-Dialysis CKD

Shenyang Sunshine Pharmaceutical Co., LTD.86 enrolled

Overview

This study primarily evaluates the efficacy and safety of oral SSS17 capsules in treating anemia in patients with non-dialysis chronic kidney disease, as well as the pharmacokinetic and pharmacodynamic (PK/PD) characteristics of different doses of SSS17 capsules for anemia treatment in this patient population.

This dose-finding study comprises three distinct dosing cohorts:cohort 1-3 once weekly . Each cohort will enroll patients at a 4:1 ratio (SSS17:placebo), allocating 32 subjects to active treatment and 8 to placebo control per group. The total planned enrollment is 120 non-dialysis chronic kidney disease (CKD) patients with anemia. The trial will initiate with Cohort 1. Dosing regimens for subsequent cohorts may be modified based on predefined pharmacokinetic (PK), pharmacodynamic (PD), and safety evaluations from preceding cohorts, including potential adjustments to dose levels and/or administration frequency.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Anemia in Pre-Dialysis Patients

Interventions

SSS17DRUG

The SSS17 treatment arm comprises three dose levels: the first two dose levels will have an 8-week treatment duration, while the third dose level will extend to 24 weeks. At each dose level, participants will be allocated in a 4:1 ratio (SSS17:placebo) for enrollment.

PlaceboDRUG

At each dose level, participants will be allocated in a 4:1 ratio (SSS17:placebo) for enrollment.Placebo recipients will undergo weekly dosing identical to the active treatment group within their assigned dose cohort.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Non-dialysis CKD patients aged 18-75 years. 2. Screening eGFR \<60 mL/min/1.73 m² . 3. Mean Hb ≥7.0 g/dL and \<10.0 g/dL . 4. Agreement to use medically acceptable contraception from ICF signing until 6 months post-trial. Exclusion Criteria: 1. Hypoxia-inducible factor prolyl hydroxylase inhibitors within 5 weeks pre-randomization. 2. Erythropoiesis-stimulating agents, androgens, IV iron , or other anemia drugs within 6 weeks pre-randomization. 3. Blood donation/transfusion within 3 months 4. Transferrin saturation ≤20% and ferritin ≤100 μg/L at screening. 5. Uncorrected folate or vitamin B12 deficiency pre-randomization. 6. Systolic BP \>170 mmHg, diastolic BP \>110 mmHg. 7. iPTH \>500 pg/mL. 8. Acute/chronic pancreatitis or amylase/lipase \>3×ULN. 9. NYHA Class III/IV heart failure or significant arrhythmias . 10. Proliferative diabetic retinopathy, macular edema, or other neovascular retinal disorders requiring treatment. 11. Active HBV, HCV, HIV, or clinically significant uncontrolled infections. 12. Current/pplanned dialysis, prior nephrectomy, polycystic kidney disease, or hemochromatosis. 13. Organ transplant recipient/candidate，Participation in other drug trials within 3 months，Substance abuse history. 14. Pregnancy, lactation, or refusal of contraception. 15. Hypersensitivity to study drug components.

Locations (1)

Peking University People's Hospital

Beijing, China

Outcomes

Primary Outcomes

Changes in hemoglobin from baseline

Time frame: Week7~Week9

Secondary Outcomes

Weekly changes in hemoglobin from baseline

Time frame: Week2~Week9

Proportion of subjects achieving hemoglobin response (≥10 g/dL)

Time frame: Week7~Week9

Cumulative proportion of subjects achieving both Hb increase ≥10 g/L and Hb level ≥100 g/L

Time frame: Week9

Data from ClinicalTrials.gov

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