Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Chronic Kidney Disease on Dialysis
Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Chronic Kidney Disease on Dialysis
Brief Summary:
The purpose of this study is to evaluate the effecacy and safety of dialysis centers switching its dialysis patients from using recombinant human erythropoietin injection (CHO Cell) (ESPO) to Pegol-Sihematide injection on hemoglobin levels and other parameters.
Detailed Description:
This is a phase 3, randomized, multicenter, open-label, active-controlled, non-inferiority trial to evaluate the efficacy and safety of from ESPO to monthly Pegol-Sihematide injection for the treatment of anemia in participants with chronic kidney disease（CKD）, who are on maintenance dialysis. Study included a period of 4 weeks for screening, 8 weeks for baseline, 16 weeks for dose adjustment, 8 weeks for evaluation, and 28 weeks for extensional treatment period. All patients who passed the screening were received ESPO in baseline period, then, eligible patients were centrally allocated in a 2:1 ratio to receive Pegol-Sihematide or ESPO. Doses of both drugs were adjusted to achieve and maintain hemoglobin levels between 10.0 and 12.0 g per deciliter for 52 weeks or more. The primary efficacy end point was the mean change from the baseline hemoglobin level to the mean level during the evaluation period; non-inferiority was established if the lower limit of the two-sided 95% confidence interval was -1.0 g per deciliter or higher. Cardiovascular safety was evaluated on the basis of an adjudicated composite end point.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter, Non-Inferiority Study to Evaluate the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Chronic Kidney Disease on Dialysis
Actual Study Start Date: May 15, 2019
Actual Primary Completion Date: February 28, 2021
Estimated Study Completion Date: September 30, 2021
Arm:
- Experimental: Pegol-Sihematide
- Active Comparator: ESPO (Recombinant Human Erythropoietin Injection)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 330 |
| Actual Study start date | 15 May 2019 |
| Estimated Study Completion Date | 30 September 2021 |