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New hope for kidney patients: drug safely lowers dangerous potassium levels

NCT ID NCT05136664

Disease control Sponsor: Vifor Fresenius Medical Care Renal Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called patiromer in 262 Chinese adults with chronic kidney disease and high potassium levels. Participants took patiromer for 4 weeks, then some switched to placebo for 8 weeks to see if potassium stayed controlled. The goal was to manage potassium safely while allowing patients to continue their heart-protective medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

262 people

The number who actually took part.

Started

Feb 2022

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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/L at baseline. * \- Subjects on any stable dose of at least 1 RAASi medication for at least 28 days before 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 contraception throughout the study and for 4 weeks after study completion. Exclusion Criteria: * \- Any level of hyperkalemia at Day 0/baseline that, in the opinion of the Investigator, 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 beginning of the study. * \- Diseases affecting the hearth muscle and heart's ability to pump blood around the body * \- Major surgery including thoracic and cardiac within 3 months prior to the beginning of the study or anticipated need during study participation. * \- Heart or kidney transplant recipient or anticipated need for transplant during study 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 prior to Day 0/baseline. * \- Pregnant women or breastfeeding.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome Hyperkalemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperkalemia Renal insufficiency, chronic

Contacts and locations

Locations

  • Investigator Site 001

    Hangzhou, Zhejiang, 310003, China

  • Investigator Site 002

    Changzhou, Jiangsu, 213004, China

  • Investigator Site 003

    Lanzhou, Gansu, 730030, China

  • Investigator Site 004

    Chengdu, Sichuan, 610044, China

  • Investigator Site 005

    Xuzhou, Jiangsu, 221004, China

  • Investigator Site 006

    Changsha, Hunan, 410013, China

  • Investigator Site 007

    Changchun, Jilin, 130041, China

  • Investigator Site 008

    Hefei, Anhui, 230601, China

  • Investigator Site 009

    Hefei, Anhui, 230022, China

  • Investigator Site 010

    Wuhan, Hubei, 430060, China

  • Investigator Site 011

    Yuncheng, Shanxi, 044099, China

  • Investigator Site 012

    Lanzhou, Gansu, 730013, China

  • Investigator Site 013

    Zhenjiang, Jiangsu, 210031, China

  • Investigator Site 014

    Tianjin, Tianjin Municipality, 300052, China

  • Investigator Site 015

    Shanghai, Shanghai Municipality, 200040, China

  • Investigator Site 016

    Beijing, Beijing Municipality, 100029, China

  • Investigator Site 018

    Yinchuan, Ningxia, 750003, China

  • Investigator Site 019

    Nanjing, Jiangsu, 210029, China

  • Investigator Site 020

    Hanzhou, Zhejiang, 310014, China

  • Investigator Site 021

    Wuxi, Jiangsu, 214023, China

  • Investigator Site 022

    Taiyuan, Shanxi, 030012, China

  • Investigator Site 023

    Ürümqi, Xinjiang, 830001, China

  • Investigator Site 024

    Nanyang, Henan, 473000, China

  • Investigator Site 025

    Jinhua, Zhejiang, 322000, China

  • Investigator Site 026

    Jiaxing, Zhejiang, 314000, China

  • Investigator Site 027

    Zhuzhou, Tianyuan District, 412007, China

  • Investigator Site 028

    Shanghai, Pudong New Area, 200120, China

  • Investigator Site 030

    Nanning, Guangxi, 530000, China

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