Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

NCT05136664 | Completed Phase 3

• 2 other identifiers: PAT-CHINA-303CTR20212173
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 28

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.

Conditions

Hyperkalemia; Renal Insufficiency, Chronic

Keywords

Hyperkalemia; Chronic kidney disease

Outcome Measures

Primary Outcomes (2)

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

  Measured in milliequivalents per litre (mEq/L)

  Week 4

• 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 Outcomes (3)

• 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

Study Arms (3)

Part A: Patiromer

EXPERIMENTAL

Part A: 4-week, single-arm patiromer treatment phase (4 weeks)

Drug: Patiromer Powder for Oral Suspension (Part A)

Part B: Placebo

PLACEBO COMPARATOR

Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase

Drug: Placebo (Part B)

Part B: Patiromer

EXPERIMENTAL

Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase

Drug: Patiromer Powder for Orals Suspension (Part B)

Interventions

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.

Part B: Placebo

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.

Part A: Patiromer

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.

Part B: Patiromer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Vifor Fresenius Medical Care Renal Pharma: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (28)

Investigator Site 009

Hefei, Anhui, 230022, China

Location

Investigator Site 008

Hefei, Anhui, 230601, China

Location

Investigator Site 016

Beijing, Beijing Municipality, 100029, China

Location

Investigator Site 012

Lanzhou, Gansu, 730013, China

Location

Investigator Site 003

Lanzhou, Gansu, 730030, China

Location

Investigator Site 030

Nanning, Guangxi, 530000, China

Location

Investigator Site 024

Nanyang, Henan, 473000, China

Location

Investigator Site 010

Wuhan, Hubei, 430060, China

Location

Investigator Site 006

Changsha, Hunan, 410013, China

Location

Investigator Site 002

Changzhou, Jiangsu, 213004, China

Location

Investigator Site 019

Nanjing, Jiangsu, 210029, China

Location

Investigator Site 021

Wuxi, Jiangsu, 214023, China

Location

Investigator Site 005

Xuzhou, Jiangsu, 221004, China

Location

Investigator Site 013

Zhenjiang, Jiangsu, 210031, China

Location

Investigator Site 007

Changchun, Jilin, 130041, China

Location

Investigator Site 018

Yinchuan, Ningxia, 750003, China

Location

Investigator Site 028

Shanghai, Pudong New Area, 200120, China

Location

Investigator Site 015

Shanghai, Shanghai Municipality, 200040, China

Location

Investigator Site 022

Taiyuan, Shanxi, 030012, China

Location

Investigator Site 011

Yuncheng, Shanxi, 044099, China

Location

Investigator Site 004

Chengdu, Sichuan, 610044, China

Location

Investigator Site 014

Tianjin, Tianjin Municipality, 300052, China

Location

Investigator Site 027

Zhuzhou, Tianyuan District, 412007, China

Location

Investigator Site 023

Ürümqi, Xinjiang, 830001, China

Location

Investigator Site 001

Hangzhou, Zhejiang, 310003, China

Location

Investigator Site 020

Hanzhou, Zhejiang, 310014, China

Location

Investigator Site 026

Jiaxing, Zhejiang, 314000, China

Location

Investigator Site 025

Jinhua, Zhejiang, 322000, China

Location

MeSH Terms

Conditions

Hyperkalemia; Renal Insufficiency, Chronic

Interventions

Suspensions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Julian Platon, MD, PhD

  CSL Vifor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 29, 2021
• Study Start: February 10, 2022
• Primary Completion: November 18, 2025
• Study Completion: November 18, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (28)