NCT04456803

Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

A Study to Evaluate the Efficacy and Safety of Ferric Citrate Tablet for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Sinomune Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of ferric citrate tablet in the control of serum phosphorus levels in patients with chronic kidney disease undergoing hemodialysis.

Detailed description

This is a multicenter, randomized, open-label, parallel, phase III study. This study is consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12 weeks). The subjects with regular hemodialysis should stop using the phosphorus binder before the Washout period. During the Treatment period, the subjects will be randomly assigned to the ferric citrate tablets group (study group) or sevelamer carbonate tablet group (control group) in the ratio of 1:1.

Conditions

• Hyperphosphatemia
• End Stage Renal Disease
• ESRD

Interventions

Type	Name	Description
DRUG	Ferric citrate tablet	250mg/tablet, manufactured by Sinomune Pharmaceutical
DRUG	Sevelamer carbonate tablet	800 mg/tablet, manufactured by Genzyme Ireland Limited

Timeline

• Start date: 2019-05-24
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2020-07-07
• Last updated: 2024-04-17

Locations

20 sites across 1 country: China