NCT07014631CompletedPhase 2
Phase II Dose-Finding of Oral SSS17 for Anemia in Non-Dialysis CKD
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
Source: ClinicalTrials.gov · Last updated 18 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (actual)
- First submitted
- 3 Jun 2025
- Start date
- 1 Mar 2023
- Primary completion date
- 12 Dec 2024
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Diseases
- Chronic kidney disease
- NCT number
- NCT07014631
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 86
- From 1 Mar 2023 to the primary completion date, 12 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
- Hypersensitivity to study drug components.
Lab values
- Transferrin saturation ≤20% and ferritin ≤100 μg/L at screening.
- Acute/chronic pancreatitis or amylase/lipase \>3×ULN.
Other
- Blood donation/transfusion within 3 months
- Uncorrected folate or vitamin B12 deficiency pre-randomization.
- Systolic BP \>170 mmHg, diastolic BP \>110 mmHg.
- iPTH \>500 pg/mL.
- Pregnancy, lactation, or refusal of contraception.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.