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An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis

Primary Purpose

Hyperkalemia

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

patiromer

About this trial

This is an interventional treatment trial for Hyperkalemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants on hemodialysis between the ages of 18 and 70 years, with serum potassium levels of at least 5.5 mmol/L
Adequately dialyzed (Kt/V ≥ 1.2)

Exclusion Criteria:

History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery.
Severe constipation or irregular bowel habits.
Unable to consume or tolerate the study-specific diet.

Sites / Locations

Investigator Site
Investigator Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patiromer

Arm Description

Outcomes

Primary Outcome Measures

Change in Serum Potassium (Day 1 to Day 8)

Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)

Secondary Outcome Measures

Full Information

NCT ID

NCT02033317

First Posted

January 9, 2014

Last Updated

May 10, 2021

Sponsor

Relypsa, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02033317

Brief Title

An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis

Official Title

An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Hemodialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Terminated

Why Stopped

Study terminated due to slow enrollment

Study Start Date

August 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Relypsa, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

Detailed Description

The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study. This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperkalemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

patiromer

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

patiromer

Other Intervention Name(s)

RLY5016 for Oral Suspension, Veltassa

Intervention Description

15 grams/day (5 grams 3 times daily) administered orally

Primary Outcome Measure Information:

Title

Change in Serum Potassium (Day 1 to Day 8)

Time Frame

Day 1 and Day 8

Title

Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)

Time Frame

Day -7 Through Day -1 and Day 1 Through Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants on hemodialysis between the ages of 18 and 70 years, with serum potassium levels of at least 5.5 mmol/L Adequately dialyzed (Kt/V ≥ 1.2) Exclusion Criteria: History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery. Severe constipation or irregular bowel habits. Unable to consume or tolerate the study-specific diet.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

VP Clinical Development

Organizational Affiliation

Relypsa, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Investigator Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Investigator Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

12. IPD Sharing Statement

Learn more about this trial

An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis

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