Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

Phase 3

Recruiting

• Conditions: Hyperkalemia; Renal Insufficiency, Chronic
• Interventions: Drug: Placebo (Part B); Drug: Patiromer Powder for Oral Suspension (Part A); Drug: Patiromer Powder for Orals Suspension (Part B)

• Registration Number: NCT05136664
• Lead Sponsor: Vifor Fresenius Medical Care Renal Pharma

Brief 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.

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.

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-29
• Study Start: 2022-02-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-11
• Primary Completion: 2025-07-30
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 290

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part B: Placebo	Placebo (Part B)	Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase
Part A: Patiromer	Patiromer Powder for Oral Suspension (Part A)	Part A: 4-week, single-arm patiromer treatment phase (4 weeks)
Part B: Patiromer	Patiromer Powder for Orals Suspension (Part B)	Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase

Primary Outcome Measures

Name	Time	Method
Part A: Change from baseline in the serum potassium (sK+)	Week 4	Measured in milliequivalents per litre (mEq/L)
Part B: Change from Week 4 in sK+	The earlier of: Week 8 or the date when RAASi therapy is first decreased or discontinued	Measured in mEq/L

Secondary Outcome Measures

Name	Time	Method
Part A: Proportion of participants having an sK+ level between 3.8 and less than 5.1 mEq/L at Week 4	Week 4
Part B: Proportion of participants taking any RAASi medication at Week 12	Week 12
Part B: Proportion of subjects discontinuing/reducing RAASi medication due to hyperkalemia	From Week 4 to 2 weeks after the end of treatment

Trial Locations

Locations (29)

Investigator Site 009; 🇨🇳 Hefei, Anhui, China

Investigator Site 008; 🇨🇳 Hefei, Anhui, China

Investigator Site 016; 🇨🇳 Beijing, Beijing, China

Investigator Site 012; 🇨🇳 Lanzhou, Gansu, China

Investigator Site 003; 🇨🇳 Lanzhou, Gansu, China

Investigator Site 029; 🇨🇳 Guangzhou, Guangdong, China

Investigator Site 030; 🇨🇳 Nanning, Guangxi, China

Investigator Site 024; 🇨🇳 Nanyang, Henan, China

Investigator Site 010; 🇨🇳 Wuhan, Hubei, China

Investigator Site 006; 🇨🇳 Changsha, Hunan, China

Investigator Site 002; 🇨🇳 Changzhou, Jiangsu, China

Investigator Site 019; 🇨🇳 Nanjing, Jiangsu, China

Investigator Site 021; 🇨🇳 Wuxi, Jiangsu, China

Investigator Site 005; 🇨🇳 Xuzhou, Jiangsu, China

Investigator Site 013; 🇨🇳 Zhenjiang, Jiangsu, China

Investigator Site 007; 🇨🇳 Changchun, Jilin, China

Investigator Site 018; 🇨🇳 Yinchuan, Ningxia, China

Investigator Site 028; 🇨🇳 Shanghai, Pudong New Area, China

Investigator Site 015; 🇨🇳 Shanghai, Shanghai, China

Investigator Site 022; 🇨🇳 Taiyuan, Shanxi, China

Investigator Site 011; 🇨🇳 Yuncheng, Shanxi, China

Investigator Site 004; 🇨🇳 Chengdu, Sichuan, China

Investigator Site 014; 🇨🇳 Tianjin, Tianjin, China

Investigator Site 027; 🇨🇳 Zhuzhou, Tianyuan District, China

Investigator Site 023; 🇨🇳 Ürümqi, Xinjiang, China

Investigator Site 001; 🇨🇳 Hangzhou, Zhejiang, China

Investigator Site 020; 🇨🇳 Hanzhou, Zhejiang, China

Investigator Site 026; 🇨🇳 Jiaxing, Zhejiang, China

Investigator Site 025; 🇨🇳 Jinhua, Zhejiang, China