Skip to main content
OpenTrials
Completed

NCT Number: NCT05136664

Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperkalemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigator Site 008, Hefei, Anhui, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patiromer Powder for Oral Suspension (Part A)

Drug

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)

Drug

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)

Drug

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.

Primary outcomes

  1. Part A: Change from baseline in the serum potassium (sK+)

    Time frame: Week 4

    Measured in milliequivalents per litre (mEq/L)

  2. Part B: Change from Week 4 in sK+

    Time frame: The earlier of: Week 8 or the date when RAASi therapy is first decreased or discontinued

    Measured in mEq/L

Secondary outcomes

  1. Part A: Proportion of participants having an sK+ level between 3.8 and less than 5.1 mEq/L at Week 4

    Time frame: Week 4

  2. Part B: Proportion of participants taking any RAASi medication at Week 12

    Time frame: Week 12

  3. Part B: Proportion of subjects discontinuing/reducing RAASi medication due to hyperkalemia

    Time frame: From Week 4 to 2 weeks after the end of treatment

Sponsors and collaborators

Lead sponsor

Vifor Fresenius Medical Care Renal Pharma

Industry

Collaborators

  • Tigermed Consulting Co., Ltd

Registry information

Official study 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)

Acronym: Patiromer JADE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2021
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.