A Phase 4 interventional study of Pegmolesatide in Renal Anemia in Non-dialysis Chronic Kidney Disease, sponsored by The First Affiliated Hospital of Dalian Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by The First Affiliated Hospital of Dalian Medical University · Phase 4, Interventional, and Treatment
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.
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 160 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →The First Affiliated Hospital of Dalian Medical University is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aged ≥18 years and ≤80 years, regardless of gender;
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;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Pegmolesatide
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.
Drug: Pegmolesatide
Pegmolesatide Injection: Specification 1mL: 4.0mg (National Medical Products Administration Approval No. H20230020), administered once every 4 weeks
Also known as: EPO-018B
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.
Time frame: the 24th week of treatment.
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.
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
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
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
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
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
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)
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.
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
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
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
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
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
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
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
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
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
Changes of mean Hb levels of populations with different baseline characteristics from baseline at week 24 of the treatment period.
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
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
Plan to share: No — The Principal Investigator have not yet considered when and in what form to share the data
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The First Affiliated Hospital of Dalian Medical University