Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia

  • STATUS
    Recruiting
  • End date
    Sep 10, 2022
  • participants needed
    54
  • sponsor
    Vifor Pharma, Inc.
Updated on 10 June 2021
Investigator
EMERALD Clinical Study Team
Primary Contact
Investigator Site 7501 (3.5 mi away) Contact
+45 other location

Summary

The purpose of this study is to evaluate the change in serum (blood) 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.

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).

Details
Condition Hyperkalemia
Treatment Patiromer
Clinical Study IdentifierNCT03087058
SponsorVifor Pharma, Inc.
Last Modified on10 June 2021

Eligibility

Yes No Not Sure

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
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