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Patiromer With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)

Primary Purpose

Hyperkalemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
patiromer
Sponsored by
Relypsa, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperkalemia focused on measuring Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease

Eligibility Criteria

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

Key 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

Key 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

Sites / Locations

  • Investigator Site 12
  • Investigator Site 11
  • Investigator Site 38
  • Investigator Site 20
  • Investigator Site 21
  • Investigator Site 24
  • Investigator Site 30
  • Investigator Site 10
  • Investigator Site 13
  • Investigator Site 17
  • Investigator Site 16
  • Investigator Site 15
  • Investigator Site 43
  • Investigator Site 18
  • Investigator Site 27
  • Investigator Site 44
  • Investigator Site 39
  • Investigator Site 23
  • Investigator Site 34
  • Investigator Site 41
  • Investigator Site 37
  • Investigator Site 36
  • Investigator Site 40
  • Investigator Site 33
  • Investigator Site 26
  • Investigator Site 29
  • Investigator Site 28
  • Investigator Site 25
  • Investigator Site 22

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 - Dosing Without Food

Group 2 - Dosing With Food

Arm Description

Patiromer dosing without food

Patiromer dosing with food

Outcomes

Primary Outcome Measures

Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4

Secondary Outcome Measures

Mean Change in Serum Potassium From Baseline to Week 4
An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model.

Full Information

First Posted
February 25, 2016
Last Updated
May 10, 2021
Sponsor
Relypsa, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02694744
Brief Title
Patiromer With or Without Food for the Treatment of Hyperkalemia
Acronym
TOURMALINE
Official Title
The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Relypsa, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia
Keywords
Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Dosing Without Food
Arm Type
Experimental
Arm Description
Patiromer dosing without food
Arm Title
Group 2 - Dosing With Food
Arm Type
Active Comparator
Arm Description
Patiromer dosing with food
Intervention Type
Drug
Intervention Name(s)
patiromer
Other Intervention Name(s)
Veltassa, RLY5016 for Oral Suspension
Intervention Description
8.4 g/day starting dose, administered orally
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Mean Change in Serum Potassium From Baseline to Week 4
Description
An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model.
Time Frame
Baseline to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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 Key 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director or VP Clinical Development
Organizational Affiliation
Relypsa, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site 12
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Investigator Site 11
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Investigator Site 38
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Investigator Site 20
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Investigator Site 21
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Investigator Site 24
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Investigator Site 30
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Investigator Site 10
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Investigator Site 13
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Investigator Site 17
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313-1638
Country
United States
Facility Name
Investigator Site 16
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Investigator Site 15
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Investigator Site 43
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Investigator Site 18
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Investigator Site 27
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Investigator Site 44
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Investigator Site 39
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Investigator Site 23
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Investigator Site 34
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Investigator Site 41
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Investigator Site 37
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Investigator Site 36
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Investigator Site 40
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Investigator Site 33
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigator Site 26
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78202
Country
United States
Facility Name
Investigator Site 29
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Investigator Site 28
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Investigator Site 25
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigator Site 22
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32588430
Citation
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.
Results Reference
derived

Learn more about this trial

Patiromer With or Without Food for the Treatment of Hyperkalemia

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