Anemia in Pre-Dialysis Patients
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSSS17
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.
DRUGPlacebo
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.
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in hemoglobin from baseline | Week7~Week9 |
Secondary
| Measure | Time frame |
|---|---|
| Weekly changes in hemoglobin from baseline | Week2~Week9 |
| Proportion of subjects achieving hemoglobin response (≥10 g/dL) | Week7~Week9 |
| Cumulative proportion of subjects achieving both Hb increase ≥10 g/L and Hb level ≥100 g/L | Week9 |
Countries
China
Outcome results
None listed