Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

Launched by VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA · Nov 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called patiromer to see how well it works and if it’s safe for people with a condition known as hyperkalemia, which means they have high potassium levels in their blood. The trial is specifically looking at Chinese adults who have chronic kidney disease (CKD) stages 3 and 4. To be eligible, participants must be at least 18 years old and have had certain potassium level measurements. They should also be on a stable dose of specific heart medications for at least 28 days before joining the study.

The trial has two main parts: the first part lasts 4 weeks, where participants will receive patiromer, and the second part lasts 8 weeks, where some will receive a placebo (a look-alike pill with no active medicine) to see how they do without the medication. There is also a 2-week follow-up period after the study. Participants can expect regular check-ups and monitoring of their potassium levels throughout the trial. It's important to note that certain medical conditions or recent surgeries may prevent some individuals from participating, so it’s a good idea to discuss any health concerns with a healthcare provider before considering joining the study.

Gender

ALL

Eligibility criteria

• 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.