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

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)

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).

Study Overview

• Status: Completed
• Conditions: Hyperkalemia
• Intervention / Treatment: Drug: patiromer

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Investigator Site 12
    • Huntington Beach, California, United States, 92648
      • Investigator Site 11
    • Palm Springs, California, United States, 92262
      • Investigator Site 38
    • Riverside, California, United States, 92505
      • Investigator Site 20
    • San Dimas, California, United States, 91773
      • Investigator Site 21
  • Colorado
    • Denver, Colorado, United States, 80230
      • Investigator Site 24
  • Florida
    • Edgewater, Florida, United States, 32132
      • Investigator Site 30
    • Hialeah, Florida, United States, 33012
      • Investigator Site 10
    • Hollywood, Florida, United States, 33021
      • Investigator Site 13
    • Lauderdale Lakes, Florida, United States, 33313-1638
      • Investigator Site 17
    • Lauderdale Lakes, Florida, United States, 33319
      • Investigator Site 16
    • Miami, Florida, United States, 33015
      • Investigator Site 15
    • Miami, Florida, United States, 33147
      • Investigator Site 43
    • Pembroke Pines, Florida, United States, 33028
      • Investigator Site 18
    • Tampa, Florida, United States, 33614
      • Investigator Site 27
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Investigator Site 44
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Investigator Site 39
  • Michigan
    • Flint, Michigan, United States, 48504
      • Investigator Site 23
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Investigator Site 34
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Investigator Site 41
  • New York
    • Flushing, New York, United States, 11355
      • Investigator Site 37
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Investigator Site 36
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Investigator Site 40
  • Texas
    • Dallas, Texas, United States, 75231
      • Investigator Site 33
    • San Antonio, Texas, United States, 78202
      • Investigator Site 26
    • San Antonio, Texas, United States, 78207
      • Investigator Site 29
    • San Antonio, Texas, United States, 78215
      • Investigator Site 28
    • San Antonio, Texas, United States, 78229
      • Investigator Site 25
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Investigator Site 22

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - Dosing Without Food; Patiromer dosing without food	Drug: patiromer; 8.4 g/day starting dose, administered orally; Other Names: Veltassa; RLY5016 for Oral Suspension
Active Comparator: Group 2 - Dosing With Food; Patiromer dosing with food	Drug: patiromer; 8.4 g/day starting dose, administered orally; Other Names: Veltassa; RLY5016 for Oral Suspension

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Day 28

Collaborators and Investigators

• Sponsor: Relypsa, Inc.
• Investigators: Study Director: Study Director or VP Clinical Development, Relypsa, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Potassium; Treatment of Hyperkalemia; Hyperkalemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia
• Other Study ID Numbers: RLY5016-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No