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.
Up to 54 subjects, 2 - \< 18 years of age with CKD (estimated glomerular filtration rate \[eGFR\] \< 90 mL/min/1.73 m2 ) and hyperkalemia (two potassium measurements of 5.1 to \< 6.5 mEq/L performed on separate days) will be enrolled in this open-label, multiple-dose, Phase 2 study. The study will include two treatment phases: Pharmacodynamic (PD; drug effect on potassium) / Dose Finding Phase consisting of the initial 14-day dose finding period followed by an up to 5.5-month Long-Term Treatment Phase for a total study participation duration for individual subjects of up to 6.5 months (includes a 2 week follow up period).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Investigator Site 1107
Change in Serum Potassium Levels
Time frame: from Baseline to Day 14
Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L
Day 14: Initial PD / Dose Finding Phase. Week 26: Long-Term Treatment Phase.
Time frame: Day 14 and Week 26
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Palo Alto, California, United States
Investigator Site 1101
Kansas City, Kansas, United States
Investigator Site 1103
Baltimore, Maryland, United States
Investigator Site 1102
The Bronx, New York, United States
Investigator Site 1105
Cincinnati, Ohio, United States
Investigator Site 1108
Pittsburgh, Pennsylvania, United States
Investigator Site 1104
Amarillo, Texas, United States
Investigator Site 1109
Dallas, Texas, United States
Investigator Site 1113
Houston, Texas, United States
Investigator Site 1106
Madison, Wisconsin, United States
...and 20 more locations