Patiromer With or Without Food for the Treatment of Hyperkalemia

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Relypsa, Inc.
Study ID
NCT02694744
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • patiromer — DRUG
    8.4 g/day starting dose, administered orally

Study Details

The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood).

Key Dates

Start date
Feb 29, 2016
Status verified
May 2021
Primary completion
Jul 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 - Dosing Without Food
    Patiromer dosing without food
  • Active Comparator: Group 2 - Dosing With Food
    Patiromer dosing with food

Primary Outcome Measure

Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 [ Time Frame: 21 to 28 Days ]

Locations (29)

FacilityCityStateZIPSite coordinators
Investigator Site 12Fountain ValleyCalifornia92708-
Investigator Site 11Huntington BeachCalifornia92648-
Investigator Site 38Palm SpringsCalifornia92262-
Investigator Site 20RiversideCalifornia92505-
Investigator Site 21San DimasCalifornia91773-
Investigator Site 24DenverColorado80230-
Investigator Site 30EdgewaterFlorida32132-
Investigator Site 10HialeahFlorida33012-
Investigator Site 13HollywoodFlorida33021-
Investigator Site 16Lauderdale LakesFlorida33319-
Investigator Site 17Lauderdale LakesFlorida33313-1638-
Investigator Site 15MiamiFlorida33015-
Investigator Site 43MiamiFlorida33147-
Investigator Site 18Pembroke PinesFlorida33028-
Investigator Site 27TampaFlorida33614-
Investigator Site 44MeridianIdaho83642-
Investigator Site 39AuroraIllinois60504-
Investigator Site 23FlintMichigan48504-
Investigator Site 34Kansas CityMissouri64111-
Investigator Site 41Las VegasNevada89106-
Investigator Site 37FlushingNew York11355-
Investigator Site 36NormanOklahoma73069-
Investigator Site 40JacksonTennessee38305-
Investigator Site 33DallasTexas75231-
Investigator Site 25San AntonioTexas78229-
Investigator Site 26San AntonioTexas78202-
Investigator Site 28San AntonioTexas78215-
Investigator Site 29San AntonioTexas78207-
Investigator Site 22Salt Lake CityUtah84124-

Find similar trials in Fountain Valley, CA

By research site
Investigator· Fountain Valley, CAInvestigator· Huntington Beach, CAInvestigator· Palm Springs, CAInvestigator· Riverside, CAInvestigator· San Dimas, CAInvestigator· Denver, CO

Related Studies