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Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects
Sponsor: Vifor Fresenius Medical Care Renal Pharma
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
Conditions
Interventions
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.
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.
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