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

NCT07014631 | Completed Phase 2

• 1 other identifier: SYSS-SSS17-RA-II-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia in Pre-Dialysis Patients

Outcome Measures

Primary Outcomes (1)

• Changes in hemoglobin from baseline

  Week7~Week9

Secondary Outcomes (3)

• 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

Study Arms (2)

SSS17

EXPERIMENTAL

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: SSS17

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

SSS17 DRUG

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.

SSS17

Placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• NYHA Class III/IV heart failure or significant arrhythmias .
• Proliferative diabetic retinopathy, macular edema, or other neovascular retinal disorders requiring treatment.
• Active HBV, HCV, HIV, or clinically significant uncontrolled infections.
• Current/pplanned dialysis, prior nephrectomy, polycystic kidney disease, or hemochromatosis.
• Organ transplant recipient/candidate，Participation in other drug trials within 3 months，Substance abuse history.
• Pregnancy, lactation, or refusal of contraception.
• Hypersensitivity to study drug components.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: March 1, 2023
• Primary Completion: December 12, 2024
• Study Completion: April 8, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

CN (1)