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

Sponsor
Vifor Pharma, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03087058
Collaborator
(none)
23
Enrollment
30
Locations
3
Arms
48
Actual Duration (Months)
0.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
May 1, 2017
Actual Primary Completion Date :
Jan 13, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in serum potassium (K+) levels from Baseline to Day 14 [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) [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) [Up to Month 6]

      Proportions and associated 95% confidence interval will be presented.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Investigator Site 1107 Palo Alto California United States 94394
    2 Investigator Site 1101 Kansas City Kansas United States 64108
    3 Investigator Site 1103 Baltimore Maryland United States 21287
    4 Investigator Site 1102 Bronx New York United States 10467
    5 Investigator Site 1105 Cincinnati Ohio United States 45229
    6 Investigator Site 1108 Pittsburgh Pennsylvania United States 15224
    7 Investigator Site 1104 Amarillo Texas United States 79106
    8 Investigator Site 1109 Dallas Texas United States 75235
    9 Investigator Site 1113 Houston Texas United States 77030
    10 Investigator Site 1106 Madison Wisconsin United States 53792
    11 Investigator Site 1401 Sofia Bulgaria 1606
    12 Investigator Site 1902 Vancouver British Columbia Canada V5Z 4H4
    13 Investigator Site 3915 Tbilisi Georgia 0121
    14 Investigator Site 3913 Tbilisi Georgia 0144
    15 Investigator Site 3911 Tbilisi Georgia 0159
    16 Investigator Site 3912 Tbilisi Georgia 0159
    17 Investigator Site 3914 Tbilisi Georgia 0159
    18 Investigator Site 4312 Essen Germany 45147
    19 Investigator Site 4313 Hannover Germany 30625
    20 Investigator Site 4311 Heidelberg Germany 69120
    21 Investiagor Site 4314 Köln Germany 50937
    22 Investigator Site 5401 Bialystok Poland 15-274
    23 Investigator Site 5404 Gdansk Poland 80-952
    24 Investigator Site 5406 Krakow Poland 30-663
    25 Investigator Site 5402 Lodz Poland 93-338
    26 Investigator Site 5403 Lublin Poland 20-093
    27 Investigator Site 5405 Warsaw Poland 02-091
    28 Investigator Site 7906 Dnipropetrovs'k Ukraine 49000
    29 Investigator Site 7903 Kharkiv Ukraine 61075
    30 Investigator Site 7904 Kyiv Ukraine 04050

    Sponsors and Collaborators

    • Vifor Pharma, Inc.

    Investigators

    • Study Director: Udo-Michael Göhring, Vifor Pharma, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vifor Pharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT03087058
    Other Study ID Numbers:
    • RLY5016-206p
    • 2016-002785-31
    First Posted:
    Mar 22, 2017
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    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 Vifor Pharma, Inc.
    Treatment of Hyperkalemia
    Hyperkalemia
    Potassium
    Chronic Kidney Disease
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Hyperkalemia

    Study Results

    No Results Posted as of Jun 15, 2022