Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

Renal Insufficiency, Chronic Clinical Trial

— Patiromer JADE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05136664
• Other study ID #: PAT-CHINA-303
• Secondary ID: CTR20212173
• Status: Recruiting
• Phase: Phase 3
• Start date: February 10, 2022
• Est. completion date: November 2026

Study information

• Verified date: April 2024
• Source: Vifor Fresenius Medical Care Renal Pharma
• Contact: PAT-CHINA-303 Clinical Study Team
• Phone: +41 588 518 000
• Email: clinicaltrials[@]cslbehring.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperkalemia
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Investigator Site 016	Beijing	Beijing
China	Investigator Site 007	Changchun	Jilin
China	Investigator Site 006	Changsha	Hunan
China	Investigator Site 002	Changzhou	Jiangsu
China	Investigator Site 004	Chengdu	Sichuan
China	Investigator Site 001	Hangzhou	Zhenjiang
China	Investigator Site 020	Hanzhou	Zhengjiang
China	Investigator Site 008	Hefei	Anhui
China	Investigator Site 009	Hefei	Anhui
China	Investigator Site 003	Lanzhou	Gansu
China	Investigator Site 012	Lanzhou	Gansu
China	Investigator Site 019	Nanjing	Jiangsu
China	Investigator Site 024	Nanyang	Henan
China	Investigator Site 015	Shanghai	Shanghai
China	Investigator Site 022	Taiyuan	Shanxi
China	Investigator Site 014	Tianjin	Tianjin
China	Investigator Site 023	Ürümqi	Xinjiang
China	Investigator Site 010	Wuhan	Hubei
China	Investigator Site 021	Wuxi	Jiangsu
China	Investigator Site 005	Xuzhou	Jiangsu
China	Investigator Site 018	Yinchuan	Ningxia
China	Investigator Site 011	Yuncheng	Shanxi
China	Investigator Site 013	Zhenjiang	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Vifor Fresenius Medical Care Renal Pharma	Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Change from baseline in the serum potassium (sK+)	Measured in milliequivalents per litre (mEq/L)	Week 4
Primary	Part B: Change from Week 4 in sK+	Measured in mEq/L	The earlier of: Week 8 or the date when RAASi therapy is first decreased or discontinued
Secondary	Part A: Proportion of participants having an sK+ level between 3.8 and less than 5.1 mEq/L at Week 4		Week 4
Secondary	Part B: Proportion of participants taking any RAASi medication at Week 12		Week 12
Secondary	Part B: Proportion of subjects discontinuing/reducing RAASi medication due to hyperkalemia		From Week 4 to 2 weeks after the end of treatment