CompletedPhase 2

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

China86 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Non-dialysis CKD patients aged 18-75 years.
✓. Screening eGFR \<60 mL/min/1.73 m² .
✓. Mean Hb ≥7.0 g/dL and \<10.0 g/dL .
✓. Agreement to use medically acceptable contraception from ICF signing until 6 months post-trial.

Exclusion criteria

✕. Hypoxia-inducible factor prolyl hydroxylase inhibitors within 5 weeks pre-randomization.
✕. Erythropoiesis-stimulating agents, androgens, IV iron , or other anemia drugs within 6 weeks pre-randomization.
✕. Blood donation/transfusion within 3 months
✕. Transferrin saturation ≤20% and ferritin ≤100 μg/L at screening.
✕. Uncorrected folate or vitamin B12 deficiency pre-randomization.
✕. Systolic BP \>170 mmHg, diastolic BP \>110 mmHg.
✕. iPTH \>500 pg/mL.
✕. Acute/chronic pancreatitis or amylase/lipase \>3×ULN.

What they're measuring

Changes in hemoglobin from baseline

Timeframe: Week7~Week9

Trial details

NCT IDNCT07014631

SponsorShenyang Sunshine Pharmaceutical Co., LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-12

View on ClinicalTrials.gov More Anemia in Pre-Dialysis Patients trials