Anemia in Pre-Dialysis PatientsPhase 2NCT07014631
Phase II Dose-Finding of Oral SSS17 for Anemia in Non-Dialysis CKD
A Phase 2 study testing SSS17 in people with Anemia in Pre-Dialysis Patients, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia in Pre-Dialysis Patients
- What is being tested?
- SSS17
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 8 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- SSS17, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSS17Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: SSS17 |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hemoglobin from baseline
Measured: Week7~Week9
Secondary outcomes (3)
Weekly changes in hemoglobin from baseline
Measured: Week2~Week9
Proportion of subjects achieving hemoglobin response (≥10 g/dL)
Measured: Week7~Week9
Cumulative proportion of subjects achieving both Hb increase ≥10 g/L and Hb level ≥100 g/L
Measured: Week9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Mar 2023
- Primary completion12 Dec 2024
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia in Pre-Dialysis PatientsStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014631
- Sponsor's protocol ID
- SYSS-SSS17-RA-II-01
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07014631
- Acronym / sponsor ID
- SYSS-SSS17-RA-II-01
- Conditions
- Anemia in Pre-Dialysis Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSS17 | Experimental | Drug: SSS17The 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 comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSS17The 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 |
| PlaceboAt 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. | Drug | placebo |
Primary outcome
Changes in hemoglobin from baseline
Time frame: Week7~Week9
3 secondary outcomes
Weekly changes in hemoglobin from baseline
Time frame: Week2~Week9
Proportion of subjects achieving hemoglobin response (≥10 g/dL)
Time frame: Week7~Week9
Cumulative proportion of subjects achieving both Hb increase ≥10 g/L and Hb level ≥100 g/L
Time frame: Week9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSS17 in people with Anemia in Pre-Dialysis Patients, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in hemoglobin from baseline (time frame: Week7~Week9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.