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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Vifor Pharma, Inc.
Study ID
NCT03087058
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Patiromer — DRUG
    4.2 g/day, 8.4 g/day and 16.8 g/day
  • Patiromer — DRUG
    2 g/day, 4 g/day and 8 g/day
  • Patiromer — DRUG
    1 g/day, 2 g/day and 4 g/day

Study Details

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.

Key Dates

Start date
Jul 7, 2017
Status verified
Oct 2022
Primary completion
Jan 13, 2021
Completion
Apr 30, 2021

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Patiromer for age 12 to \< 18 years
  • Experimental: Cohort 2
    Patiromer for age 6 to \< 12 years
  • Experimental: Cohort 3
    Patiromer for age 2 to \< 6 years

Primary Outcome Measure

Change in Serum Potassium Levels [ Time Frame: from Baseline to Day 14 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Investigator Site 1107Palo AltoCalifornia94394-
Investigator Site 1101Kansas CityKansas64108-
Investigator Site 1103BaltimoreMaryland21287-
Investigator Site 1102The BronxNew York10467-
Investigator Site 1105CincinnatiOhio45229-
Investigator Site 1108PittsburghPennsylvania15224-
Investigator Site 1104AmarilloTexas79106-
Investigator Site 1109DallasTexas75235-
Investigator Site 1113HoustonTexas77030-
Investigator Site 1106MadisonWisconsin53792-

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