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Completed

NCT Number: NCT03183778

Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.

The purpose of this proof-of-concept controlled-feeding study is to determine whether patiromer (Veltassa®, Relypsa, Inc., Redwood City, CA) can be used to maintain normal serum potassium concentrations in chronic kidney disease (CKD) patients who are transitioned to a plant-rich diet.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperkalemia 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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stages 3B-4 CKD (estimated glomerular filtration rate (eGFR) of 15-44 mL/min/1.73m2, not treated with dialysis)
  • No prior treatment with patiromer
  • Mild hyperkalemia (potassium 5.1 to <6.5 mEq/L) on one of the last two blood tests
  • No prior episodes of moderate-severe hyperkalemia (potassium ≥6.5 mEq/L) in the past 6 months
  • Deemed appropriate for the intervention by the patient's nephrologist, considering the patient's prognosis, cognition and pending treatments (e.g., dialysis)

Exclusion criteria

  • Change in medications that alter potassium homeostasis (e.g., RAAS inhibitors, diuretics, β-blockers) in the last month
  • Diagnosed with bowel diseases or syndromes (e.g., bowel obstruction, major GI surgery, short-bowel syndrome, irritable bowel syndrome, inflammatory bowel disease, chronic diarrhea)
  • Dietary restrictions (e.g., allergies) or otherwise unable/unwilling to adhere to study diets (excludes dietary restrictions on high-potassium foods)
  • Pregnant (females) or planning to become pregnant (males and females) during the study

Treatment and study plan

patiromer

Drug

Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.

Other names: Veltassa

Research Diet Menu

Dietary Supplement

During the study, participants will be asked to consume only the foods provided in the research diet

Primary outcomes

  1. Change in Fasting Serum Potassium Concentrations

    Time frame: Baseline, Week 2

  2. Change in Fasting Serum Potassium Concentrations

    Time frame: Baseline, Week 4

  3. Change in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 2

  4. Change in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 4

  5. Change in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 2

  6. Change in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 4

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2017
Registry last updated
Dec 1, 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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