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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:10/10/2018
Start Date:March 12, 2018
End Date:April 2019
Contact:David Goldfarb
Email:david.goldfarb@nyumc.org
Phone:212 263 0744

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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.


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
We found this trial at
1
site
462 1st Avenue
New York, New York 10010
Principal Investigator: David St. Jules, MD
Phone: 212-263-0744
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New York, NY
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