Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
NCT ID: NCT03087058
Last Updated: 2022-10-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
23 participants
INTERVENTIONAL
2017-07-07
2021-04-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
Patiromer for age 12 to \< 18 years
Patiromer
4.2 g/day, 8.4 g/day and 16.8 g/day
Cohort 2
Patiromer for age 6 to \< 12 years
Patiromer
2 g/day, 4 g/day and 8 g/day
Cohort 3
Patiromer for age 2 to \< 6 years
Patiromer
1 g/day, 2 g/day and 4 g/day
Interventions
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Patiromer
4.2 g/day, 8.4 g/day and 16.8 g/day
Patiromer
2 g/day, 4 g/day and 8 g/day
Patiromer
1 g/day, 2 g/day and 4 g/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
17 Years
ALL
No
Sponsors
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Vifor Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Julian Platon, MD, PhD
Role: STUDY_DIRECTOR
Vifor Pharma, Inc.
Locations
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Investigator Site 1107
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
Investigator Site 1401
Sofia, , Bulgaria
Investigator Site 1902
Vancouver, British Columbia, Canada
Investigator Site 3915
Tbilisi, , Georgia
Investigator Site 3913
Tbilisi, , Georgia
Investigator Site 3911
Tbilisi, , Georgia
Investigator Site 3912
Tbilisi, , Georgia
Investigator Site 3914
Tbilisi, , Georgia
Investiagor Site 4314
Cologne, , Germany
Investigator Site 4312
Essen, , Germany
Investigator Site 4313
Hanover, , Germany
Investigator Site 4311
Heidelberg, , Germany
Investigator Site 5401
Bialystok, , Poland
Investigator Site 5404
Gdansk, , Poland
Investigator Site 5406
Krakow, , Poland
Investigator Site 5402
Lodz, , Poland
Investigator Site 5403
Lublin, , Poland
Investigator Site 5405
Warsaw, , Poland
Investigator Site 7906
Dnipro, , Ukraine
Investigator Site 7903
Kharkiv, , Ukraine
Investigator Site 7904
Kyiv, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002785-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RLY5016-206p
Identifier Type: -
Identifier Source: org_study_id
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