Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

Last updated: April 10, 2026
Sponsor: Vifor Fresenius Medical Care Renal Pharma
Overall Status: Completed

Phase

3

Condition

Kidney Failure (Pediatric)

Nephropathy

Kidney Disease

Treatment

Patiromer Powder for Orals Suspension (Part B)

Placebo (Part B)

Patiromer Powder for Oral Suspension (Part A)

Clinical Study ID

NCT05136664
PAT-CHINA-303
CTR20212173
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    • Chinese subjects at least 18 years of age.
    • Chronic Kidney Disease (CKD) stage 3 and 4.
    • Mean of 2 measurement of serum potassium higher than 5.0 and lower than 6.5 mEq/Lat baseline.
    • Subjects on any stable dose of at least 1 RAASi medication for at least 28 daysbefore Day 0/baseline.
    • If on antihypertensive medication, have a stable dose for 28 days before Day 0/baseline.
    • Women of childbearing potential must agree to continue using contraceptionthroughout the study and for 4 weeks after study completion.

Exclusion

Exclusion Criteria:

    • Any level of hyperkalemia at Day 0/baseline that, in the opinion of theInvestigator, requires emergency intervention.
    • Type 1 diabetes or Type 2 diabetes mellitus with glycated haemoglobin (Hb A1c)higher than 10.0% at screening/Part A baseline.
    • History of acute renal insufficiency in the past 3 months prior to the beginningof the study.
    • Diseases affecting the hearth muscle and heart's ability to pump blood around thebody
    • Major surgery including thoracic and cardiac within 3 months prior to thebeginning of the study or anticipated need during study participation.
    • Heart or kidney transplant recipient or anticipated need for transplant duringstudy participation
    • Diagnosis or treatment of a malignancy in the past 2 years before Day 0/baseline.
    • Use of potassium supplements, bicarbonate or baking soda in the last 7 days priorto Day 0/baseline.
    • Pregnant women or breastfeeding.

Study Design

Total Participants: 262
Treatment Group(s): 3
Primary Treatment: Patiromer Powder for Orals Suspension (Part B)
Phase: 3
Study Start date:
February 10, 2022
Estimated Completion Date:
November 18, 2025

Study 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.

Connect with a study center

  • Investigator Site 008

    Hefei, Anhui 230601
    China

    Site Not Available

  • Investigator Site 009

    Hefei, Anhui 230022
    China

    Site Not Available

  • Investigator Site 008

    Hefei 1808722, Anhui 1818058 230601
    China

    Site Not Available

  • Investigator Site 009

    Hefei 1808722, Anhui 1818058 230022
    China

    Site Not Available

  • Investigator Site 016

    Beijing, Beijing Municipality 100029
    China

    Site Not Available

  • Investigator Site 016

    Beijing 1816670, Beijing Municipality 2038349 100029
    China

    Site Not Available

  • Investigator Site 003

    Lanzhou, Gansu 730030
    China

    Site Not Available

  • Investigator Site 012

    Lanzhou, Gansu 730013
    China

    Site Not Available

  • Investigator Site 003

    Lanzhou 1804430, Gansu 1810676 730030
    China

    Site Not Available

  • Investigator Site 012

    Lanzhou 1804430, Gansu 1810676 730013
    China

    Site Not Available

  • Investigator Site 029

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Investigator Site 029

    Guangzhou 1809858, Guangdong 1809935 510060
    China

    Site Not Available

  • Investigator Site 030

    Nanning, Guangxi 530000
    China

    Site Not Available

  • Investigator Site 030

    Nanning 1799869, Guangxi 1809867 530000
    China

    Site Not Available

  • Investigator Site 024

    Nanyang, Henan 473000
    China

    Site Not Available

  • Investigator Site 024

    Nanyang 1799629, Henan 1808520 473000
    China

    Site Not Available

  • Investigator Site 010

    Wuhan, Hubei 430060
    China

    Site Not Available

  • Investigator Site 010

    Wuhan 1791247, Hubei 1806949 430060
    China

    Site Not Available

  • Investigator Site 006

    Changsha, Hunan 410013
    China

    Site Not Available

  • Investigator Site 006

    Changsha 1815577, Hunan 1806691 410013
    China

    Site Not Available

  • Investigator Site 002

    Changzhou, Jiangsu 213004
    China

    Site Not Available

  • Investigator Site 019

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Investigator Site 021

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • Investigator Site 005

    Xuzhou, Jiangsu 221004
    China

    Site Not Available

  • Investigator Site 013

    Zhenjiang, Jiangsu 210031
    China

    Site Not Available

  • Investigator Site 002

    Changzhou 1815456, Jiangsu 1806260 213004
    China

    Site Not Available

  • Investigator Site 019

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Site Not Available

  • Investigator Site 021

    Wuxi 1790923, Jiangsu 1806260 214023
    China

    Site Not Available

  • Investigator Site 005

    Xuzhou 10630003, Jiangsu 1806260 221004
    China

    Site Not Available

  • Investigator Site 013

    Zhenjiang 1784642, Jiangsu 1806260 210031
    China

    Site Not Available

  • Investigator Site 007

    Changchun, Jilin 130041
    China

    Site Not Available

  • Investigator Site 007

    Changchun 2038180, Jilin 2036500 130041
    China

    Site Not Available

  • Investigator Site 018

    Yinchuan, Ningxia 750003
    China

    Site Not Available

  • Investigator Site 018

    Yinchuan 1786657, Ningxia 1799355 750003
    China

    Site Not Available

  • Investigator Site 028

    Shanghai, Pudong New Area 200120
    China

    Site Not Available

  • Investigator Site 028

    Shanghai 1796236, Pudong New Area 200120
    China

    Site Not Available

  • Investigator Site 015

    Shanghai, Shanghai Municipality 200040
    China

    Site Not Available

  • Investigator Site 015

    Shanghai 1796236, Shanghai Municipality 1796231 200040
    China

    Site Not Available

  • Investigator Site 022

    Taiyuan, Shanxi 030012
    China

    Site Not Available

  • Investigator Site 011

    Yuncheng, Shanxi 044099
    China

    Site Not Available

  • Investigator Site 022

    Taiyuan 1793511, Shanxi 1795912 030012
    China

    Site Not Available

  • Investigator Site 011

    Yuncheng 1785738, Shanxi 1795912 044099
    China

    Site Not Available

  • Investigator Site 004

    Chengdu, Sichuan 610044
    China

    Site Not Available

  • Investigator Site 004

    Chengdu 1815286, Sichuan 1794299 610044
    China

    Site Not Available

  • Investigator Site 014

    Tianjin, Tianjin Municipality 300052
    China

    Site Not Available

  • Investigator Site 014

    Tianjin 1792947, Tianjin Municipality 1792943 300052
    China

    Site Not Available

  • Investigator Site 027

    Zhuzhou, Tianyuan District 412007
    China

    Site Not Available

  • Investigator Site 027

    Zhuzhou 1783763, Tianyuan District 412007
    China

    Site Not Available

  • Investigator Site 023

    Ürümqi, Xinjiang 830001
    China

    Site Not Available

  • Investigator Site 023

    Ürümqi 1529102, Xinjiang 1529047 830001
    China

    Site Not Available

  • Investigator Site 001

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Investigator Site 020

    Hanzhou, Zhejiang 310014
    China

    Site Not Available

  • Investigator Site 026

    Jiaxing, Zhejiang 314000
    China

    Site Not Available

  • Investigator Site 025

    Jinhua, Zhejiang 322000
    China

    Site Not Available

  • Investigator Site 001

    Hangzhou 1808926, Zhejiang 1784764 310003
    China

    Site Not Available

  • Investigator Site 026

    Jiaxing 1805953, Zhejiang 1784764 314000
    China

    Site Not Available

  • Investigator Site 025

    Jinhua 1805528, Zhejiang 1784764 322000
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.