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

NCT07014631 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-06-18

No results posted yet for this study

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.

Conditions

  • Anemia in Pre-Dialysis Patients

Interventions

DRUG

SSS17

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.

DRUG

Placebo

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 & Collaborators

  • Shenyang Sunshine Pharmaceutical Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-12-12
Completion
2025-04-08

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07014631 on ClinicalTrials.gov