A Phase II Dose-Finding Study to Evaluate the Efficacy and Safety of Oral SSS17 Capsules for Anemia in Non-Dialysis Chronic Kidney Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Changes in hemoglobin from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: SSS17 (Drug)
placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in hemoglobin from baseline
时间窗: Week7~Week9
次要结局
- 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)