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

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ClinicalTrials.gov Identifier: NCT03087058
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Relypsa, Inc.

Brief 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.

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] < 60 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 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 : May 1, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Patiromer

Arm Intervention/treatment
Experimental: Cohort 1
Patiromer for age 12 ‒ < 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 ‒ < 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 ‒ < 6 years
Drug: Patiromer
1 g/day, 2 g/day and 4 g/day
Other Names:
  • Veltassa
  • RLY5016 for Oral Suspension




Primary Outcome Measures :
  1. Change in serum potassium levels from Baseline to Day 14 [ Time Frame: Baseline and Day 14 ]
    Changes in serum potassium levels will be summarized by starting dose and age group using descriptive statistics. Descriptive statistics include mean, standard deviation, and 95% confidence intervals.


Secondary Outcome Measures :
  1. Proportion of subjects with serum K+ levels in the range of 3.8 - 5.0 mEq/L at Day 14 (Initial PD / Dose Finding Phase) [ Time Frame: Day 14 ]
    Proportions and associated exact 95% confidence interval will be presented.

  2. Proportion of subjects with serum K+ levels in the range of 3.8 - 5.0 mEq/L by visit at any time through Month 6 (Long-Term Treatment Phase) [ Time Frame: Up to Month 6 ]
    Proportions and associated 95% confidence interval will be presented.



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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 eGFR <60 mL/min/1.73m2 including renal transplant, peritoneal dialysis
  • 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 months
  • 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:

  • False elevation in blood potassium (pseudohyperkalemia) due to hemolysis (breaking of blood cells) or abnormally high counts of blood cells at Screening
  • Evidence of potassium-related electrocardiogram (ECG) changes at Screening
  • Any of the following kidney conditions: hemodialysis, 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
  • 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)
  • Have had a heart or liver transplant, or anticipated need for transplant during the study treatment period including a scheduled kidney transplant. (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

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


Contacts
Contact: Head of Clinical Operations 650-421-9500 emerald@relypsa.com

  Show 38 Study Locations
Sponsors and Collaborators
Relypsa, Inc.
Investigators
Study Director: Study Director or VP Clinical Development Relypsa, Inc.

Responsible Party: Relypsa, Inc.
ClinicalTrials.gov Identifier: NCT03087058     History of Changes
Other Study ID Numbers: RLY5016-206p
2016-002785-31 ( EudraCT Number )
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Relypsa, Inc.:
Treatment of Hyperkalemia
Hyperkalemia
Potassium
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperkalemia
Urologic Diseases
Renal Insufficiency
Water-Electrolyte Imbalance
Metabolic Diseases