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Patiromer With or Without Food for the Treatment of Hyperkalemia

NCT ID: NCT02694744

Last Updated: 2021-05-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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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).

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Detailed Description

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Approximately 110 eligible participants with hyperkalemia will be randomly assigned to receive a patiromer starting dose of 8.4- g/day, either with or without food.

All participants will undergo a screening period (1 day) to determine eligibility for study entry. Eligible participants will be treated for 4 weeks and followed for 2 weeks after completing the patiromer treatment. There are six planned clinic visits during the Treatment Period and two planned visits after the last dose of patiromer during the Follow-up Period.

The dose of patiromer may be increased or decreased (titrated) based on participants' individual potassium response.

Conditions

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Hyperkalemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 - Dosing Without Food

Patiromer dosing without food

Group Type EXPERIMENTAL

patiromer

Intervention Type DRUG

8.4 g/day starting dose, administered orally

Group 2 - Dosing With Food

Patiromer dosing with food

Group Type ACTIVE_COMPARATOR

patiromer

Intervention Type DRUG

8.4 g/day starting dose, administered orally

Interventions

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patiromer

8.4 g/day starting dose, administered orally

Intervention Type DRUG

Other Intervention Names

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Veltassa RLY5016 for Oral Suspension

Eligibility Criteria

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Inclusion Criteria

* Potassium concentration \> 5.0 mEq/L from two blood draws at Screening
* Stable RAASi medication, if taking
* Medications taken on a chronic basis are given once daily or twice daily
* Informed consent given

Exclusion Criteria

* Expected need for dialysis
* Major organ transplant
* History of conditions associated with pseudohyperkalemia
* History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
* Cancer or unstable medical condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Relypsa, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director or VP Clinical Development

Role: STUDY_DIRECTOR

Relypsa, Inc.

Locations

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Investigator Site 12

Fountain Valley, California, United States

Site Status

Investigator Site 11

Huntington Beach, California, United States

Site Status

Investigator Site 38

Palm Springs, California, United States

Site Status

Investigator Site 20

Riverside, California, United States

Site Status

Investigator Site 21

San Dimas, California, United States

Site Status

Investigator Site 24

Denver, Colorado, United States

Site Status

Investigator Site 30

Edgewater, Florida, United States

Site Status

Investigator Site 10

Hialeah, Florida, United States

Site Status

Investigator Site 13

Hollywood, Florida, United States

Site Status

Investigator Site 17

Lauderdale Lakes, Florida, United States

Site Status

Investigator Site 16

Lauderdale Lakes, Florida, United States

Site Status

Investigator Site 15

Miami, Florida, United States

Site Status

Investigator Site 43

Miami, Florida, United States

Site Status

Investigator Site 18

Pembroke Pines, Florida, United States

Site Status

Investigator Site 27

Tampa, Florida, United States

Site Status

Investigator Site 44

Meridian, Idaho, United States

Site Status

Investigator Site 39

Aurora, Illinois, United States

Site Status

Investigator Site 23

Flint, Michigan, United States

Site Status

Investigator Site 34

Kansas City, Missouri, United States

Site Status

Investigator Site 41

Las Vegas, Nevada, United States

Site Status

Investigator Site 37

Flushing, New York, United States

Site Status

Investigator Site 36

Norman, Oklahoma, United States

Site Status

Investigator Site 40

Jackson, Tennessee, United States

Site Status

Investigator Site 33

Dallas, Texas, United States

Site Status

Investigator Site 26

San Antonio, Texas, United States

Site Status

Investigator Site 29

San Antonio, Texas, United States

Site Status

Investigator Site 28

San Antonio, Texas, United States

Site Status

Investigator Site 25

San Antonio, Texas, United States

Site Status

Investigator Site 22

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.

Reference Type DERIVED
PMID: 32588430 (View on PubMed)

Other Identifiers

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RLY5016-401

Identifier Type: -

Identifier Source: org_study_id

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