Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

Korábbi kezelés

• - History of acute renal insufficiency in the past 3 months prior to the beginning of the study.
• - Major surgery including thoracic and cardiac within 3 months prior to the beginning of the study or anticipated need during study participation.

Más betegség

• - Diseases affecting the hearth muscle and heart's ability to pump blood around the body
• - 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.

Laborértékek

• - Type 1 diabetes or Type 2 diabetes mellitus with glycated haemoglobin (Hb A1c) higher than 10.0% at screening/Part A baseline.
• - Use of potassium supplements, bicarbonate or baking soda in the last 7 days prior to Day 0/baseline.

Egyéb

• - Any level of hyperkalemia at Day 0/baseline that, in the opinion of the Investigator, requires emergency intervention.
• - Pregnant women or breastfeeding.

• - 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.