Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
Condition: Hyperkalemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperkalemia
Intervention: Patiromer; Patiromer; Patiromer
Intervention description: 4.2 g/day, 8.4 g/day and 16.8 g/day; 2 g/day, 4 g/day and 8 g/day; 1 g/day, 2 g/day and 4 g/day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Treatment of Hyperkalemia; Hyperkalemia; Potassium; Chronic Kidney Disease

Summary:

      The purpose of this study is to evaluate the change in serum potassium levels from start of
      treatment to Day 14, when patiromer is administered at different doses, once daily, in
      children 2 - < 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too much
      potassium in the blood). Another purpose of the study is to evaluate the safety and
      tolerability of patiromer in children 2 - < 18 years of age with CKD and hyperkalemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written assent (when applicable) and written informed consent by a legally authorized
             representative provided prior to participation in the study

          -  Age 2 - <18 years old

          -  CKD defined by the estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m2,
             including renal transplant subjects, based on local creatinine measurement at
             screening

          -  Two potassium measurements of 5.1 to < 6.5 mEq/L performed on separate days

          -  In the opinion of the study doctor, is expected to require treatment for hyperkalemia
             for at least 6 month

          -  If taking any renin-angiotensin-aldosterone system inhibitors (RAASi) beta blockers or
             diuretic medications, must be on a stable dose for at least 28 days prior to Screening

          -  Negative pregnancy test in females of child-bearing potential

        Exclusion Criteria:

          -  Pseudohyperkalemia due to hemolysis or to abnormally high numbers of platelets
             (>500,000/mm3), leukocytes (>70,000/mm3), or erythrocytes (hematocrit >55%) at
             Screening based on results obtained locally

          -  Evidence of potassium-related electrocardiogram (ECG) changes at Screening

          -  Any of the following kidney conditions: maintenance hemodialysis or peritoneal
             dialysis, renal artery stenosis, and acute kidney injury or a history of acute renal
             insufficiency in the past 3 months

          -  Severe disorder of stomach or intestines including surgery that could affect
             gastrointestinal transit of the drug

          -  Increased liver enzymes (ALT, AST > 3 times upper limit of normal) at Screening

          -  Active cancer, currently on cancer treatment or history of cancer in the past 2 years
             (except for non-melanoma skin cancer)

          -  Heart or liver transplant, or anticipated need for transplant during the study
             treatment period including a scheduled kidney transplant recipient. (Note: patients
             currently on a kidney transplant wait list are not excluded unless there is an
             identified donor).

          -  Alcohol abuse or substance use disorder within 1 year of Screening

          -  Subjects currently being treated with or having taken any one of the following
             medications (includes resins) in the 7 days prior to Screening: sodium or calcium
             polystyrene sulfonate, drospirenone

          -  Use of certain medications that can affect blood potassium levels if doses have not
             been stable for at least 14 days prior to Screening or if doses are anticipated to
             change during the 14-day PD / Dose Finding Phase

          -  Use of investigational product within 30 days of screening or within 5 half-lives,
             whichever is longer

          -  Known hypersensitivity to patiromer or its components

          -  In the opinion of the Investigator, any medical condition, uncontrolled systemic
             disease, or serious intercurrent illness that would significantly decrease study
             compliance or jeopardize the safety of the subject or potentially affect the quality
             of the data