Phase 4
N=3
Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
Chronic Kidney Diseases · Hyperkalemia
Bottom Line
View on ClinicalTrials.gov: NCT03183778 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Change in Fasting Serum Potassium Concentrations — -0.2 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Patiromer (Drug); Research Diet Menu (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fasting Serum Potassium Concentrations |
0.7 | — |
| PRIMARY Change in Fasting Serum Potassium Concentrations |
0.7 | — |
| PRIMARY Change in Systolic Blood Pressure (SBP) |
-14.9 | — |
| PRIMARY Change in Systolic Blood Pressure (SBP) |
-14.9 | — |
| PRIMARY Change in Diastolic Blood Pressure (DBP) |
-4.3 | — |
| PRIMARY Change in Diastolic Blood Pressure (DBP) |
-4.3 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03183778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.