Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
- Registration Number
- NCT03087058
- Lead Sponsor
- Vifor Pharma, Inc.
- Brief 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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 Patiromer Patiromer for age 12 to \< 18 years Cohort 2 Patiromer Patiromer for age 6 to \< 12 years Cohort 3 Patiromer Patiromer for age 2 to \< 6 years
- Primary Outcome Measures
Name Time Method Change in Serum Potassium Levels from Baseline to Day 14
- Secondary Outcome Measures
Name Time Method Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L Day 14 and Week 26 Day 14: Initial PD / Dose Finding Phase. Week 26: Long-Term Treatment Phase.
Trial Locations
- Locations (30)
Investigator Site 1101
🇺🇸Kansas City, Kansas, United States
Investigator Site 1401
🇧🇬Sofia, Bulgaria
Investigator Site 5404
🇵🇱Gdansk, Poland
Investigator Site 1902
🇨🇦Vancouver, British Columbia, Canada
Investigator Site 3912
🇬🇪Tbilisi, Georgia
Investigator Site 7906
🇺🇦Dnipropetrovs'k, Ukraine
Investigator Site 7903
🇺🇦Kharkiv, Ukraine
Investigator Site 3914
🇬🇪Tbilisi, Georgia
Investigator Site 7904
🇺🇦Kyiv, Ukraine
Investigator Site 1107
🇺🇸Palo Alto, California, United States
Investigator Site 1102
🇺🇸Bronx, New York, United States
Investigator Site 1103
🇺🇸Baltimore, Maryland, 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
Investigator Site 3915
🇬🇪Tbilisi, Georgia
Investigator Site 3913
🇬🇪Tbilisi, Georgia
Investigator Site 4311
🇩🇪Heidelberg, Germany
Investigator Site 4313
🇩🇪Hannover, Germany
Investigator Site 3911
🇬🇪Tbilisi, Georgia
Investigator Site 4312
🇩🇪Essen, Germany
Investigator Site 5401
🇵🇱Bialystok, Poland
Investiagor Site 4314
🇩🇪Köln, Germany
Investigator Site 5406
🇵🇱Krakow, Poland
Investigator Site 5402
🇵🇱Lodz, Poland
Investigator Site 5403
🇵🇱Lublin, Poland
Investigator Site 5405
🇵🇱Warsaw, Poland