Renal Anemia in Non-dialysis Chronic Kidney DiseasePhase 4NCT06946394
Use of Pegmolesatide in Renal Anemia: Efficacy and Safety of Switching to Pegmolesatide in Non-dialysis CKD Patients Treated With rhuEPO or HIF-PHI
A Phase 4 study testing Pegmolesatide in people with Renal Anemia in Non-dialysis Chronic Kidney Disease, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Anemia in Non-dialysis Chronic Kidney Disease
- What is being tested?
- Pegmolesatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years and ≤80 years, regardless of gender;
- Body weight ≥45 kg; Body Mass Index (BMI) ≥18.5 kg/m²;
- Diagnosed with chronic kidney disease (CKD) complicated by renal anemia, with an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m² before randomization (GFR estimation using the CKD-EPI formula); Undergoing continuous treatment with rHuEPO or HIF-PHI for ≥2 weeks before randomization;
- Hemoglobin (Hb) level measured within 7 days before randomization ≥70 g/L and < 110 g/L;
- Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF)
Who cannot join
- Known to have hematological disorders or other diseases that cause anemia other than chronic kidney disease (CKD), such as primary pure red cell aplasia (PRCA), homozygous sickle cell disease, thalassemia/Cooley's anemia, multiple myeloma, hemolytic anemia, and myelodysplastic syndrome, or malignant tumors;
- Known to be allergic to iron agents or polyethylene glycol;
- Received red blood cell or whole blood transfusion therapy within the three months prior to randomization;
- Having received or planned to receive anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization or during the study treatment period;
- Poorly controlled blood pressure (specific criteria for determination are referenced in Appendix II);
- C-reactive protein (CRP) ≥30 mg/L within 7 days prior to randomization;
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- Pregnant or breastfeeding women, women of childbearing age with a positive urine β-HCG test result prior to the study, or those planning to become pregnant during the study;
- Assessed as having Class C liver function within 7 days prior to randomization (Child-Pugh classification, details in Appendix IV);
- Assessed as having Class III or IV cardiac function within 28 days prior to randomization (details in Appendix III);
- Subjects deemed by the investigator to have any other factors that make them unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jilin Chen, M.D. contact
About this study
This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients which had received Recombinant human erythropoietin (rHuEPO) or Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) treatment were randomized in a 1:1 ratio to receive Pegmolesatide with different administration regimens.
Read the detailed description
This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients were randomized in a 1:1 ratio to Pegmolesatide optimize medication regimen group and Pegmolesatide standard medication regimen group. Patients in the investigational group received 2.0 mg (in patients weighing ≤60 kg) or 3.2 mg (in patients weighing >60 kg) as the initial dose, the initial dose of the control group was 0.04mg/kg, then were adjusted for every 4 weeks based on Hb levels and its changes. The primary endpoint was the change in Hb levels from baseline in week 24.
- Being tested
- Pegmolesatide
- Keywords
- Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegmolesatideDrug
Also called EPO-018B
Pegmolesatide Injection: Specification 1mL: 4.0mg (National Medical Products Administration Approval No. H20230020), administered once every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pegmolesatide utilization regimen group | Experimental | initial phase：Body weight ≤60kg, initial dose 2.0mg; Body weight > 60kg, initial dose 3.2mg, once every 4 weeks by subcutaneous injection.
Adjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection. Receives: Drug: Pegmolesatide |
| Pegmolesatide standard medication regimen group | Active comparator | initial phase：0.04mg/kg body weight, once every 4 weeks by subcutaneous injection.
Adjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection. Receives: Drug: Pegmolesatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of mean Hb levels from baseline in the standard medication regimen group and the optimized medication regimen group at week 24 of the treatment period.
Baseline Hb was defined as the assessments of Hb during 3days prior to first dose of the study treatment. Mean Hb levels at week 24 of the treatment period (Hb at week 24) was defined as the mean of Hb at day 168±5 of the treatment period. Changes of mean Hb levels from baseline in the standard medication regimen group and the optimized medication regimen group at week 24 of the treatment period was calculated by subtracting the baseline Hb from Hb at week 24.
Measured: the 24th week of treatment.
Secondary outcomes (17)
Median time for two groups of Hb values to reach the target (110-130g/L) for the first time
Median time for two groups of Hb values to reach the target (110-130g/L) for the first time.
Measured: during the 48 weeks of treatment.
The proportion of subjects with Hb average values ranging from 100-120 g/L and 110-130 g/L at each follow-up point during the treatment period in the two groups
The proportion of subjects with Hb average values ranging from 100-120 g/L and 110-130 g/L at each follow-up point during the treatment period in the two groups
Measured: During the 48-week period
Change of Hb from baseline at each follow-up point
Change of Hb from baseline at each follow-up point.
Measured: during the 48 weeks of treatment.
The absolute values of Hb levels at each follow-up point in the two groups during the treatment period
The absolute values of Hb levels at each follow-up point in the two groups during the treatment period
Measured: during the 48 weeks of treatment.
Change of red blood cell count from baseline at each follow-up point
Change of red blood cell count from baseline at each follow-up point.
Measured: during the 48 weeks of treatment.
Change of hematocrit from baseline at each follow-up point
Change of hematocrit from baseline at each follow-up point.
Measured: during the 48 weeks of treatment.
the fluctuation of Hb values between the two groups after 24 weeks (Hb variability)
It was defined as the coefficient of variation of Hb values after 24 weeks, which was calculated by dividing the SD (standard deviation) by the mean of Hb after the 24 weeks of treatment.
Measured: after the 24 weeks of treatment.
The average dose of the trial drug used between every two visits during the treatment period in the two groups
The average dose of the trial drug used between every two visits during the treatment period in the two groups
Measured: during the 48 weeks of treatment.
The average dosage of medication for subjects in both groups with mean Hb values in the range of 100-120 g/L and 110-130 g/L at each follow-up visit during the treatment period
The average dosage of medication for subjects in both groups with mean Hb values in the range of 100-120 g/L and 110-130 g/L at each follow-up visit during the treatment period
Measured: During the 48-week period
Cumulative number of dose adjustments for both groups of subjects in weeks 24 and 48
Cumulative number of dose adjustments for both groups of subjects in weeks 24 and 48.
Measured: the 24th and 48th week of treatment.
The changes in patient-reported outcomes (PROs) from baseline at week 24 in the two groups
The changes in patient-reported outcomes (PROs) from baseline at week 24 in the two groups
Measured: During the 24-week period
The proportion of all-cause death events in the two groups at the end of follow-up
The proportion of all-cause death events in the two groups at the end of follow-up
Measured: during the 48 weeks of treatment.
The proportion of cardiovascular death events in the two groups at the end of follow-up
The proportion of cardiovascular death events in the two groups at the end of follow-up
Measured: during the 48 weeks of treatment.
The proportion of stroke and myocardial infarction events in the two groups at the end of follow-up
The proportion of stroke and myocardial infarction events in the two groups at the end of follow-up
Measured: during the 48 weeks of treatment.
The proportion of subjects entering the renal replacement therapy phase in the two groups at the end of follow-up
The proportion of subjects entering the renal replacement therapy phase in the two groups at the end of follow-up
Measured: during the 48 weeks of treatment.
Therapeutic response of populations with different baseline characteristics to pegmolesatide
Changes of mean Hb levels of populations with different baseline characteristics from baseline at week 24 of the treatment period.
Measured: at the week 24 of treatment.
The changes in carbamylated EPO levels and erythropoiesis (EPO) levels from baseline at week 24 in the two groups
The changes in carbamylated EPO levels and erythropoiesis (EPO) levels from baseline at week 24 in the two groups
Measured: During the 48-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Anemia in Non-dialysis Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Hongli Lin, M.D., Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946394
- Sponsor's protocol ID
- HSM-20039-402
- Status last verified
- Sep 2025
- First submitted
- 10 Nov 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Principal Investigator have not yet considered when and in what form to share the data
Publications
Zhang P, Jiang Y, Xu C, Zhou L, Zheng H, Xie D, Guo M, Huang X, Lu G, Jiang H, Qiu H, Liu B, Li S, Chen Q, Xia Y, Sun B, Yang X, Zhang S, Du S, Sun M, Chen M, Zhong A, Wang X, Zhao Z, Zhou H, Li G, Ren Y, Luo Q, Yang A, Luo P, Tang S, Xu C, Wang Q, Wang X, Yan T, He W, Qin S, Zhang W, Lv L, Wang C, Liu H, Li J, Wu Q, Pan C, Li C, He L, Chen J. Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial. EClinicalMedicine. 2023 Oct 28;65:102273. doi: 10.1016/j.eclinm.2023.102273. eCollection 2023 Nov.
PubMed 37954906
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Pegmolesatide in Renal Anemia: Efficacy and Safety of Switching to Pegmolesatide in Non-dialysis CKD Patients Treated With rhuEPO or HIF-PHI
- ClinicalTrials.gov ID
- NCT06946394
- Acronym / sponsor ID
- HSM-20039-402
- Keywords
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Apr 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 was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients which had received Recombinant human erythropoietin (rHuEPO) or Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) treatment were randomized in a 1:1 ratio to receive Pegmolesatide with different administration regimens.
Detailed description
This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients were randomized in a 1:1 ratio to Pegmolesatide optimize medication regimen group and Pegmolesatide standard medication regimen group. Patients in the investigational group received 2.0 mg (in patients weighing ≤60 kg) or 3.2 mg (in patients weighing >60 kg) as the initial dose, the initial dose of the control group was 0.04mg/kg, then were adjusted for every 4 weeks based on Hb levels and its changes. The primary endpoint was the change in Hb levels from baseline in week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegmolesatide utilization regimen group | Experimental | Drug: Pegmolesatideinitial phase：Body weight ≤60kg, initial dose 2.0mg; Body weight > 60kg, initial dose 3.2mg, once every 4 weeks by subcutaneous injection. Adjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection. |
| Pegmolesatide standard medication regimen group | Active comparator | Drug: Pegmolesatideinitial phase：0.04mg/kg body weight, once every 4 weeks by subcutaneous injection. Adjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (10 listed)
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 |
|---|---|---|
| PegmolesatideAlso: EPO-018BPegmolesatide Injection: Specification 1mL: 4.0mg (National Medical Products Administration Approval No. H20230020), administered once every 4 weeks | Drug | Pegmolesatide standard medication regimen group, Pegmolesatide utilization regimen group |
Primary outcome
Changes of mean Hb levels from baseline in the standard medication regimen group and the optimized medication regimen group at week 24 of the treatment period.
Time frame: the 24th week of treatment.
Baseline Hb was defined as the assessments of Hb during 3days prior to first dose of the study treatment. Mean Hb levels at week 24 of the treatment period (Hb at week 24) was defined as the mean of Hb at day 168±5 of the treatment period. Changes of mean Hb levels from baseline in the standard medication regimen group and the optimized medication regimen group at week 24 of the treatment period was calculated by subtracting the baseline Hb from Hb at week 24.
17 secondary outcomes
Median time for two groups of Hb values to reach the target (110-130g/L) for the first time
Time frame: during the 48 weeks of treatment.
The proportion of subjects with Hb average values ranging from 100-120 g/L and 110-130 g/L at each follow-up point during the treatment period in the two groups
Time frame: During the 48-week period
Change of Hb from baseline at each follow-up point
Time frame: during the 48 weeks of treatment.
The absolute values of Hb levels at each follow-up point in the two groups during the treatment period
Time frame: during the 48 weeks of treatment.
Change of red blood cell count from baseline at each follow-up point
Time frame: during the 48 weeks of treatment.
Change of hematocrit from baseline at each follow-up point
Time frame: during the 48 weeks of treatment.
the fluctuation of Hb values between the two groups after 24 weeks (Hb variability)
Time frame: after the 24 weeks of treatment.
The average dose of the trial drug used between every two visits during the treatment period in the two groups
Time frame: during the 48 weeks of treatment.
The average dosage of medication for subjects in both groups with mean Hb values in the range of 100-120 g/L and 110-130 g/L at each follow-up visit during the treatment period
Time frame: During the 48-week period
Cumulative number of dose adjustments for both groups of subjects in weeks 24 and 48
Time frame: the 24th and 48th week of treatment.
The changes in patient-reported outcomes (PROs) from baseline at week 24 in the two groups
Time frame: During the 24-week period
The proportion of all-cause death events in the two groups at the end of follow-up
Time frame: during the 48 weeks of treatment.
The proportion of cardiovascular death events in the two groups at the end of follow-up
Time frame: during the 48 weeks of treatment.
The proportion of stroke and myocardial infarction events in the two groups at the end of follow-up
Time frame: during the 48 weeks of treatment.
The proportion of subjects entering the renal replacement therapy phase in the two groups at the end of follow-up
Time frame: during the 48 weeks of treatment.
Therapeutic response of populations with different baseline characteristics to pegmolesatide
Time frame: at the week 24 of treatment.
The changes in carbamylated EPO levels and erythropoiesis (EPO) levels from baseline at week 24 in the two groups
Time frame: During the 48-week period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 37954906Zhang P, Jiang Y, Xu C, Zhou L, Zheng H, Xie D, Guo M, Huang X, Lu G, Jiang H, Qiu H, Liu B, Li S, Chen Q, Xia Y, Sun B, Yang X, Zhang S, Du S, Sun M, Chen M, Zhong A, Wang X, Zhao Z, Zhou H, Li G, Ren Y, Luo Q, Yang A, Luo P, Tang S, Xu C, Wang Q, Wang X, Yan T, He W, Qin S, Zhang W, Lv L, Wang C, Liu H, Li J, Wu Q, Pan C, Li C, He L, Chen J. Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial. EClinicalMedicine. 2023 Oct 28;65:102273. doi: 10.1016/j.eclinm.2023.102273. eCollection 2023 Nov.
- Individual participant dataSharing planned: No. The Principal Investigator have not yet considered when and in what form to share the data
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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.
Jilin Chen, M.D. contact
Hongli Lin, M.D. principal investigator
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegmolesatide in people with Renal Anemia in Non-dialysis Chronic Kidney Disease, run by The First Affiliated Hospital of Dalian Medical University 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongli Lin, M.D. (13332268576, linhongli@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of mean Hb levels from baseline in the standard medication regimen group and the optimized medication regimen group at week 24 of the treatment period. (time frame: the 24th week of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06946394, which also lists 1 linked publication.
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 2 Sep 2026.