Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects — Patiromer JADE  

Renal Insufficiency, Chronic Clinical Trial

Official title: A 2-Part, Single-Blind, Phase 3 Trial Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalaemia in Chinese Subjects

Status Recruiting

Clinical Trial Summary

This is a multicentre, 2-part, single-blind, randomised, withdrawal, placebo-controlled study, that includes a 4-week patiromer treatment phase (Part A) followed by an 8-week randomised placebo-controlled withdrawal phase (Part B) and a 2-week follow-up period.

Clinical Trial Description

In Part A, participants who meet all eligibility criteria will initiate patiromer at an oral dose of 8.4 g (1 packet/day). The dose will be adjusted based on the serum potassium (sK+) levels.

After the completion of part A, all the participants who meet the eligibility criteria for Part B will be randomised to receive patiromer or placebo. Participants will start Part B with the same dose of patiromer they were receiving at the end Part A. However, Patiromer dose may be up- or down-titrated based on sK+ levels.

The primary objectives of the study are:

Part A - To evaluate the efficacy of patiromer for the treatment of hyperkalemia in Chinese subjects.

Part B - To evaluate the effect of withdrawing patiromer on sK+ control. To determine if the treatment with patiromer will result in continued use of renin-angiotensin-aldosterone system inhibitor (RAASi) medications. ;

Related Conditions & MeSH terms

• Hyperkalemia
• Renal Insufficiency
• Renal Insufficiency, Chronic

• NCT number: NCT05136664
• Study type: Interventional
• Source: Vifor Fresenius Medical Care Renal Pharma
• Contact: PAT-CHINA-303 Clinical Study Team
• Phone: +41 588 518 000
• Email: clinicaltrials@cslbehring.com
• Status: Recruiting
• Phase: Phase 3
• Start date: February 10, 2022
• Completion date: November 2026