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Completed

NCT Number: NCT02694744

Patiromer With or Without Food for the Treatment of Hyperkalemia

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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Key information

Conditions

Hyperkalemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigator Site 12, Fountain Valley, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patiromer

Drug

8.4 g/day starting dose, administered orally

Other names: Veltassa, RLY5016 for Oral Suspension

Primary outcomes

  1. 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 outcomes

  1. Mean Change in Serum Potassium From Baseline to Week 4

    Time frame: Baseline to Day 28

    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.

Sponsors and collaborators

Lead sponsor

Relypsa, Inc.

Industry

Registry information

Official study 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)

Acronym: TOURMALINE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 29, 2016
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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