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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03087058
Recruitment Status : Terminated (The study was terminated on 13 May 2022 due to a modification to the PIP/PSP)
First Posted : March 22, 2017
Results First Posted : September 26, 2022
Last Update Posted : October 19, 2022
Sponsor:
Information provided by (Responsible Party):
Vifor Pharma ( Vifor Pharma, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: Patiromer Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer for Oral Suspension in Children and Adolescents 2 to < 18 Years of Age With Chronic Kidney Disease and Hyperkalemia
Actual Study Start Date : July 7, 2017
Actual Primary Completion Date : January 13, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Patiromer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Patiromer for age 12 to < 18 years
 Drug: Patiromer
4.2 g/day, 8.4 g/day and 16.8 g/day
Other Names:
  • Veltassa
  • RLY5016 for Oral Suspension
Experimental: Cohort 2
Patiromer for age 6 to < 12 years
 Drug: Patiromer
2 g/day, 4 g/day and 8 g/day
Other Names:
  • Veltassa
  • RLY5016 for Oral Suspension
Experimental: Cohort 3
Patiromer for age 2 to < 6 years
 Drug: Patiromer
1 g/day, 2 g/day and 4 g/day
Other Names:
  • Veltassa
  • RLY5016 for Oral Suspension


Outcome Measures
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Primary Outcome Measures :
  1. Change in Serum Potassium Levels [ Time Frame: from Baseline to Day 14 ]

Secondary Outcome Measures :
  1. Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L [ Time Frame: Day 14 and Week 26 ]
    Day 14: Initial PD / Dose Finding Phase. Week 26: Long-Term Treatment Phase.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087058


Locations
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Sponsors and Collaborators
Vifor Pharma, Inc.
Investigators
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Study Director: Julian Platon, MD, PhD Vifor Pharma, Inc.
  Study Documents (Full-Text)

Documents provided by Vifor Pharma ( Vifor Pharma, Inc. ):
Study Protocol  [PDF] May 20, 2019
Statistical Analysis Plan  [PDF] September 17, 2020

More Information
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Responsible Party: Vifor Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03087058    
Other Study ID Numbers: RLY5016-206p
2016-002785-31 ( EudraCT Number )
First Posted: March 22, 2017    Key Record Dates
Results First Posted: September 26, 2022
Last Update Posted: October 19, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vifor Pharma ( Vifor Pharma, Inc. ):
Treatment of Hyperkalemia
Hyperkalemia
Potassium
Chronic Kidney Disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperkalemia
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases