A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Patiromer will be given once daily; In Cohort 3, depending on the dose and the study participant's age, the total daily dose might be split
Change in potassium levels (mmol/L)
May be measured as serum, plasma, whole blood, potassium
Time frame: From baseline to Day 28
Change in potassium levels (mmol/L)
May be measured as serum, plasma, whole blood, potassium
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Occurrence of treatment-emergent adverse events (TEAEs)
Time frame: Part 1: Day 1 up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to follow-up visit (Up to 54 weeks)
Occurrence of serious adverse events (SAEs)
Time frame: Part 1: Day 1 up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to follow-up visit (Up to 54 weeks)
Change from baseline in resting heart rate (beats per minute)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in systolic blood pressure (mmHg)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in diastolic blood pressure (mmHg)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in body temperature (Celsius)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Number of patients with ECG abnormalities
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Children's Hospital Colorado
Aurora, Colorado, United States
NOT_YET_RECRUITINGUF Health Pediatric Multispecialty Center Site
Jacksonville, Florida, United States
TERMINATEDMiller School of Medicine, University of Miami
Miami, Florida, United States
RECRUITINGArnold Palmer Hospital for Children
Orlando, Florida, United States
RECRUITINGAugusta University - Children's Hospital of Georgia
Augusta, Georgia, United States
RECRUITINGUniversity of Illinois College of Medicine
Peoria, Illinois, United States
RECRUITINGBoston Children's Hospital
Boston, Massachusetts, United States
RECRUITINGChildren's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
RECRUITINGDuke University Hospital & Medical Center
Durham, North Carolina, United States
RECRUITINGDuke University Hospital
Durham, North Carolina, United States
RECRUITING...and 27 more locations
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Calcium (mg/dL)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Phosphate (mg/dL)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Magnesium (mg/dL)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Potassium (mEq/L)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Sodium (mEq/L)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Creatinine (mg/dL)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Serum bicarbonate (mEq/L)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Blood urea nitrogen (mEq/L)
Time frame: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in haematology laboratory evaluation: White blood cells (10^9/L)
Time frame: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Change from baseline in haematology laboratory evaluation: Red blood cells count (10^12/L)
Time frame: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Change from baseline in haematology laboratory evaluation: Haemoglobin (10^12/L)
Time frame: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Change from baseline in haematology laboratory evaluation: Haematocrit (%)
Time frame: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Change from baseline in haematology laboratory evaluation: Platelet count (10^9/L)
Time frame: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Change from baseline in haematology laboratory evaluation: Blood fluoride (ng/mL)
Time frame: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Occurrence of blood potassium below the lower limit of normal (LLN) (mmol/L)
Time frame: Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks)
Occurrence of blood potassium above the upper limit of normal (ULN) (mmol/L)
Time frame: Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks)
Occurrence of blood magnesium at levels specified in protocol (mmol/L)
Time frame: Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks)
Occurrence of abnormal clinical laboratory value findings
Occurrence of clinical laboratory value findings that are outside of normal range of the respective age for: serum calcium, phosphate, fluoride, creatinine, bicarbonate, and blood urea nitrogen levels
Time frame: Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks)