Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Chinese subjects at least 18 years of age.

• Chronic Kidney Disease (CKD) stage 3 and 4.

• Serum potassium higher than 5.0 and lower than 6.5 mEq/L at Day 0/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 haemoglobin (Hb) A1c higher than 10.0% at Day 0/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.