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| Name | Class |
|---|---|
| Jiangsu Hansoh Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegmolesatide optimize medication 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegmolesatide | Drug | Pegmolesatide Injection: Specification 1mL: 4.0mg (National Medical Products Administration Approval No. H20230020), administered once every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | the 24th week of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Median time for two groups of Hb values to reach the target for the first time | Median time for two groups of Hb values to reach the target for the first time. | during the 48 weeks of treatment. |
| Proportion of subjects with Hb levels meeting the standard in two groups at each follow-up point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongli Lin, M.D. | Contact | 13332268576 | linhongli@vip.163.com | |
| Jilin Chen, M.D. | Contact | 18098875658 |
| Name | Affiliation | Role |
|---|---|---|
| Hongli Lin, M.D. | The First Affiliated Hospital of Dalian Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37954906 | Background | 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. |
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The Principal Investigator have not yet considered when and in what form to share the data
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|
Proportion of subjects with Hb levels meeting the standard in two groups at each follow-up point. |
| during the 48 weeks of treatment. |
| Change of Hb from baseline at each follow-up point | Change of Hb from baseline at each follow-up point. | 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. | 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. | 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. | after the 24 weeks of treatment. |
| The types and average doses of anti-anemia drugs of the subjects reaching the Hb target at each follow-up time point | The types and average doses of anti-anemia drugs of the subjects reaching the Hb target at each follow-up time point. | during the 48 weeks of treatment. |
| 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. | the 24th and 48th week 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. | at the week 24 of treatment. |
| Patient reported outcomes (PROs) at baseline and at week 24 in both groups | Health Survey Scale at baseline and at week 24 in both groups. | baseline and the 24th week of treatment |
| All-cause death | Number of all-cause death events during the 24/48 weeks of treatment. | during the 24/48 weeks of treatment. |
| Cardiovascular death | Number of cardiovascular death events during the 24/48 weeks of treatment. | during the 24/48 weeks of treatment. |
| Cerebral infarction and myocardial infarction | Number of Cerebral infarction and myocardial infarction events during the 24/48 weeks of treatment. | during the 24/48 weeks of treatment. |
| Receive regular renal replacement therapy | Number of subjects receive regular renal replacement therapy during the 24/48 weeks of treatment. | during the 24/48 weeks of treatment. |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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