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COMPLETED
NCT05136664
PHASE3

Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

Sponsor: Vifor Fresenius Medical Care Renal Pharma

View on ClinicalTrials.gov

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.

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 (The Patiromer JADE Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

262

Start Date

2022-02-10

Completion Date

2025-11-18

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DRUG

Patiromer Powder for Oral Suspension (Part A)

Participants initiate patiromer at an oral dose of 1 packet/day (8.4g/day as powder for suspension). The dose is adjusted ate the following visit based on local serum potassium (sK+) levels. The content of each packet should be mixed with water, apple or cranberry juice before administration.

DRUG

Placebo (Part B)

Placebo is provided in packets, each containing 6 g of placebo as powder for suspension. Participants will take 1 packet per day, by mixing its content with water, apple or cranberry juice.

DRUG

Patiromer Powder for Orals Suspension (Part B)

Participants will continue to receive the same number of packets established during Part A, but dose may be up- or down titrated depending on sK+ levels. The content of each packet should be mixed with water, apple or cranberry juice before administration.

Locations (28)

Investigator Site 009

Hefei, Anhui, China

Investigator Site 008

Hefei, Anhui, China

Investigator Site 016

Beijing, Beijing Municipality, China

Investigator Site 012

Lanzhou, Gansu, China

Investigator Site 003

Lanzhou, Gansu, China

Investigator Site 030

Nanning, Guangxi, China

Investigator Site 024

Nanyang, Henan, China

Investigator Site 010

Wuhan, Hubei, China

Investigator Site 006

Changsha, Hunan, China

Investigator Site 002

Changzhou, Jiangsu, China

Investigator Site 019

Nanjing, Jiangsu, China

Investigator Site 021

Wuxi, Jiangsu, China

Investigator Site 005

Xuzhou, Jiangsu, China

Investigator Site 013

Zhenjiang, Jiangsu, China

Investigator Site 007

Changchun, Jilin, China

Investigator Site 018

Yinchuan, Ningxia, China

Investigator Site 028

Shanghai, Pudong New Area, China

Investigator Site 015

Shanghai, Shanghai Municipality, China

Investigator Site 022

Taiyuan, Shanxi, China

Investigator Site 011

Yuncheng, Shanxi, China

Investigator Site 004

Chengdu, Sichuan, China

Investigator Site 014

Tianjin, Tianjin Municipality, China

Investigator Site 027

Zhuzhou, Tianyuan District, China

Investigator Site 023

Ürümqi, Xinjiang, China

Investigator Site 001

Hangzhou, Zhejiang, China

Investigator Site 020

Hanzhou, Zhejiang, China

Investigator Site 026

Jiaxing, Zhejiang, China

Investigator Site 025

Jinhua, Zhejiang, China