NCT03903809

Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With NDD-CKD

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 Non-Dialysis-Dependent Chronic Kidney Disease

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and efficacy of Pegol-Sihematide, as compared with recombinant human erythropoietin injection (CHO Cell), ESPO, in anemia treatment in patients with non-dialysis-dependent chronic kidney disease.

Detailed description

This is a phase 3, randomized, multicenter, open-label, active-controlled, non-inferiority trial to evaluate the safety and efficacy of Pegol-Sihematide versus ESPO. Study included a period of 4 weeks for screening, 16 weeks for dose adjustment, 8 weeks for evaluation, and 28 weeks for extensional treatment period. Eligible patients were centrally allocated in a 2:1 ratio to receive Pegol-Sihematide subcutaneously once every 4 weeks, starting at 0.04 mg per kilogram of body weight, or ESPO once every 1 week or 2 weeks, starting dose of 6000 IU per week. 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.

Conditions

• Non-Dialysis-Dependent Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Pegol-Sihematide	Participants received Pegol-Sihematide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 10.0-12.0 grams per deciliter (g/dL).
DRUG	ESPO	Participants received ESPO by subcutaneous injection weekly. The starting dose was 6000 IU and was adjusted according to the instruction to maintain a hemoglobin target range of 10.0-12.0 grams per deciliter (g/dL).

Timeline

• Start date: 2019-06-20
• Primary completion: 2021-10-14
• Completion: 2022-12-31
• First posted: 2019-04-04
• Last updated: 2022-09-01

Locations

1 site across 1 country: China