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

NCT ID: NCT07014631

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-04-08

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.

Conditions

Anemia in Pre-Dialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

SSS17

Intervention Type: 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.

placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Sunshine Pharmaceutical Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, , China

Countries

China

Other Identifiers

SYSS-SSS17-RA-II-01

Identifier Type: -

Identifier Source: org_study_id