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

Phase 2

Completed

• Conditions: Anemia in Pre-Dialysis Patients
• Interventions: Drug: SSS17; Drug: Placebo

• Registration Number: NCT07014631
• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

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.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-12-12
• Study Completion: 2025-04-08
• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1. Non-dialysis CKD patients aged 18-75 years (inclusive).
2. Screening eGFR <60 mL/min/1.73 m² (calculated per CKD-EPI Scr formula).
3. Mean Hb ≥7.0 g/dL and <10.0 g/dL from two central lab tests during screening (≥6 days apart).
4. Agreement to use medically acceptable contraception from ICF signing until 6 months post-trial.
5. Willing to provide written informed consent, communicate with investigators, and comply with protocol requirements.

Exclusion Criteria

1. Use of new/modified traditional Chinese medicines for anemia during screening.
2. Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) within 5 weeks pre-randomization.
3. Erythropoiesis-stimulating agents (ESAs), androgens, IV iron (excluding oral iron), or other anemia drugs (excluding TCM/HIF-PHIs) within 6 weeks pre-randomization.
4. Erythropoiesis-stimulating agents (ESAs), androgens, IV iron (excluding oral iron), or other anemia drugs (excluding TCM/HIF-PHIs) within 6 weeks pre-randomization.Blood donation/transfusion (≥400 mL) within 3 months
5. Transferrin saturation ≤20% and ferritin ≤100 μg/L at screening.
6. Uncorrected folate or vitamin B12 deficiency pre-randomization.
7. Uncorrected folate or vitamin B12 deficiency pre-randomization.
8. Systolic BP >170 mmHg, diastolic BP >110 mmHg, or orthostatic hypotension.
9. iPTH >500 pg/mL at screening.
10. Acute/chronic pancreatitis or amylase/lipase >3×ULN.
11. Active malignancy or history within 5 years (excluding cured basal cell carcinoma/carcinoma in situ).
12. Active malignancy or history within 5 years (excluding cured basal cell carcinoma/carcinoma in situ).
13. NYHA Class III/IV heart failure or significant arrhythmias (e.g., atrial fibrillation).
14. Proliferative diabetic retinopathy, macular edema, or other neovascular retinal disorders requiring treatment.
15. Active HBV, HCV, HIV, or clinically significant uncontrolled infections.
16. Serum albumin <3 g/dL at screening.
17. Current/pplanned dialysis, prior nephrectomy, polycystic kidney disease, or hemochromatosis.
18. Organ transplant recipient/candidate，Participation in other drug trials within 3 months，Substance abuse history.
19. Pregnancy, lactation, or refusal of contraception.
20. Hypersensitivity to study drug components.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSS17	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
placebo	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
Changes in hemoglobin from baseline	Week7~Week9

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China