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

NCT03087058 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-10-19

Study results available
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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.

Conditions

  • Hyperkalemia

Interventions

DRUG

Patiromer

4.2 g/day, 8.4 g/day and 16.8 g/day

DRUG

Patiromer

2 g/day, 4 g/day and 8 g/day

DRUG

Patiromer

1 g/day, 2 g/day and 4 g/day

Sponsors & Collaborators

  • Vifor Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Julian Platon, MD, PhD · Vifor Pharma, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2021-01-13
Completion
2021-04-30
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Georgia
  • Germany
  • Poland
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087058 on ClinicalTrials.gov