NCT05136664View on ClinicalTrials.gov

Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

PHASE3RecruitingINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

February 10, 2022

Primary Completion Date

August 31, 2025

Study Completion Date

November 30, 2025

Conditions
HyperkalemiaRenal Insufficiency, Chronic
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."

Trial Locations (29)

100029

RECRUITING

Investigator Site 016, Beijing

130041

RECRUITING

Investigator Site 007, Changchun

200040

RECRUITING

Investigator Site 015, Shanghai

200120

RECRUITING

Investigator Site 028, Shanghai

210029

RECRUITING

Investigator Site 019, Nanjing

210031

WITHDRAWN

Investigator Site 013, Zhenjiang

213004

RECRUITING

Investigator Site 002, Changzhou

214023

RECRUITING

Investigator Site 021, Wuxi

221004

RECRUITING

Investigator Site 005, Xuzhou

230022

WITHDRAWN

Investigator Site 009, Hefei

230601

RECRUITING

Investigator Site 008, Hefei

300052

TERMINATED

Investigator Site 014, Tianjin

310003

RECRUITING

Investigator Site 001, Hangzhou

310014

RECRUITING

Investigator Site 020, Hanzhou

314000

RECRUITING

Investigator Site 026, Jiaxing

322000

RECRUITING

Investigator Site 025, Jinhua

410013

RECRUITING

Investigator Site 006, Changsha

412007

RECRUITING

Investigator Site 027, Zhuzhou

430060

RECRUITING

Investigator Site 010, Wuhan

473000

RECRUITING

Investigator Site 024, Nanyang

510060

WITHDRAWN

Investigator Site 029, Guangzhou

530000

RECRUITING

Investigator Site 030, Nanning

610044

RECRUITING

Investigator Site 004, Chengdu

730013

RECRUITING

Investigator Site 012, Lanzhou

730030

WITHDRAWN

Investigator Site 003, Lanzhou

750003

RECRUITING

Investigator Site 018, Yinchuan

830001

RECRUITING

Investigator Site 023, Ürümqi

030012

RECRUITING

Investigator Site 022, Taiyuan

044099

WITHDRAWN

Investigator Site 011, Yuncheng

All Listed Sponsors
collaborator

Tigermed Consulting Co., Ltd

INDUSTRY

lead

Vifor Fresenius Medical Care Renal Pharma

INDUSTRY