Clinical trial NCT07014631: Phase II Dose-Finding of Oral SSS17 for Anemia in Non-Dialysis CKD
Official title: A Phase II Dose-Finding Study to Evaluate the Efficacy and Safety of Oral SSS17 Capsules for Anemia in Non-Dialysis Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia in Pre-Dialysis Patients
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in hemoglobin from baseline
timeFrame: Week7~Week9
Secondary outcomes:
measure: Weekly changes in hemoglobin from baseline
timeFrame: Week2~Week9
measure: Proportion of subjects achieving hemoglobin response (≥10 g/dL)
timeFrame: Week7~Week9
measure: Cumulative proportion of subjects achieving both Hb increase ≥10 g/L and Hb level ≥100 g/L
timeFrame: Week9
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References: