AzTrials
AzTrials

HyperkalemiaPhase 3Patiromer JADENCT05136664

Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

A Phase 3 study testing Patiromer Powder for Oral Suspension (Part A) and Patiromer Powder for Orals Suspension (Part B) in people with Hyperkalemia and Renal Insufficiency, Chronic, run by Vifor Fresenius Medical Care Renal Pharma at 28 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperkalemia, Renal Insufficiency, Chronic
What is being tested?
Patiromer Powder for Oral Suspension (Part A) and Patiromer Powder for Orals Suspension (Part B)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
262 participants
Where
28 sitesChina
Study dates
10 Feb 2022to 18 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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.

Who cannot join

  • - 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
Show all 9Show fewer
  • - 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.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Investigator Site 016

    Beijing, Beijing Municipality, 100029

  • Investigator Site 007

    Changchun, Jilin, 130041

  • Investigator Site 006

    Changsha, Hunan, 410013

  • Investigator Site 002

    Changzhou, Jiangsu, 213004

  • Investigator Site 004

    Chengdu, Sichuan, 610044

  • Investigator Site 001

    Hangzhou, Zhejiang, 310003

  • Investigator Site 020

    Hanzhou, Zhejiang, 310014

  • Investigator Site 009

    Hefei, Anhui, 230022

  • Investigator Site 008

    Hefei, Anhui, 230601

  • Investigator Site 026

    Jiaxing, Zhejiang, 314000

  • Investigator Site 025

    Jinhua, Zhejiang, 322000

  • Investigator Site 012

    Lanzhou, Gansu, 730013

  • Investigator Site 003

    Lanzhou, Gansu, 730030

  • Investigator Site 019

    Nanjing, Jiangsu, 210029

  • Investigator Site 030

    Nanning, Guangxi, 530000

  • Investigator Site 024

    Nanyang, Henan, 473000

  • Investigator Site 028

    Shanghai, Pudong New Area, 200120

  • Investigator Site 015

    Shanghai, Shanghai Municipality, 200040

  • Investigator Site 022

    Taiyuan, Shanxi, 030012

  • Investigator Site 014

    Tianjin, Tianjin Municipality, 300052

  • Investigator Site 023

    Ürümqi, Xinjiang, 830001

  • Investigator Site 010

    Wuhan, Hubei, 430060

  • Investigator Site 021

    Wuxi, Jiangsu, 214023

  • Investigator Site 005

    Xuzhou, Jiangsu, 221004

  • Investigator Site 018

    Yinchuan, Ningxia, 750003

  • Investigator Site 011

    Yuncheng, Shanxi, 044099

  • Investigator Site 013

    Zhenjiang, Jiangsu, 210031

  • Investigator Site 027

    Zhuzhou, Tianyuan District, 412007

Other trials in China

About this study

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)

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.

Read the detailed 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.

Being tested
Patiromer Powder for Oral Suspension (Part A), Placebo (Part B), Patiromer Powder for Orals Suspension (Part B)
Keywords
Hyperkalemia, Chronic kidney disease
Medical subject headings
Hyperkalemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05136664
Study groupRoleWhat they receive
Part A: PatiromerExperimentalPart A: 4-week, single-arm patiromer treatment phase (4 weeks)
Receives: Drug: Patiromer Powder for Oral Suspension (Part A)
Part B: PlaceboPlacebo comparatorPart B: 8-week randomized, parallel group, placebo-controlled withdrawal phase
Receives: Drug: Placebo (Part B)
Part B: PatiromerExperimentalPart B: 8-week randomized, parallel group, placebo-controlled withdrawal phase
Receives: Drug: Patiromer Powder for Orals Suspension (Part B)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured in milliequivalents per litre (mEq/L)

    Measured: Week 4

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

    Measured in mEq/L

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

Secondary outcomes (3)

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

    Measured: Week 4

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

    Measured: Week 12

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2021
  2. Study start10 Feb 2022
  3. Primary completion18 Nov 2025
  4. Study completion18 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2-part, single-blind, randomised withdrawal, placebo-controlled (Part B), parallel group study that includes a 4-week patiromer treatment phase (Part A) followed by an 8-week randomised placebo-controlled withdrawal phase (Part B).
Masking
Single blind
Who is masked
Participant
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05136664
Sponsor's protocol ID
PAT-CHINA-303
Other IDs
CTR20212173
Acronym
Patiromer JADE
Status last verified
Apr 2026
First submitted
15 Nov 2021
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Patiromer Powder for Oral Suspension (Part A) and Patiromer Powder for Orals Suspension (Part B) in people with Hyperkalemia and Renal Insufficiency, Chronic, run by Vifor Fresenius Medical Care Renal Pharma at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Change from baseline in the serum potassium (sK+) (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05136664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in