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Rationale and Design of a Randomized Placebo-Controlled Clinical Trial Assessing the Renoprotective Effects of Potassium Supplementation in Chronic Kidney Disease
- Source :
- Nephron, 140(1), 48-57. KARGER, Nephron, 140(1), 48-57, Nephron, Nephron, 140(1), 48-57. Karger
- Publication Year :
- 2018
-
Abstract
- Background/Aims: Dietary potassium (K+) has beneficial effects on blood pressure and cardiovascular (CV) outcomes. Recently, several epidemiological studies have revealed an association between urinary K+ excretion (as proxy for dietary intake) and better renal outcomes in subjects with chronic kidney disease (CKD). To address causality, we designed the “K+ in CKD” study. Methods: The K+ in CKD study is a multicenter, randomized, double blind, placebo-controlled clinical trial aiming to include 399 patients with hypertension, CKD stage 3b or 4 (estimated glomerular filtration rate [eGFR] 15–44 mL/min/1.73 m2), and an average eGFR decline > 2 mL/min/1.73 m2/year. As safety measure, all included subjects will start with a 2-week open-label phase of 40 mmol potassium chloride daily. Patients who do not subsequently develop hyperkalemia (defined as serum K+ >5.5 mmol/L) will be randomized to receive potassium chloride, potassium citrate (both K+ 40 mmol/day), or placebo for 2 years. The primary end point is the difference in eGFR after 2 years of treatment. Secondary end points include other renal outcomes (> 30% decrease in eGFR, doubling of serum creatinine, end-stage renal disease, albuminuria), ambulatory blood pressure, CV events, all-cause mortality, and incidence of hyperkalemia. Several measurements will be performed to analyze the effects of potassium supplementation, including body composition monitoring, pulse wave velocity, plasma renin and aldosterone concentrations, urinary ammonium, and intracellular K+ concentrations. Conclusion: The K+ in CKD study will demonstrate if K+ sup­plementation has a renoprotective effect in progressive CKD, and whether alkali therapy has additional beneficial effects.
- Subjects :
- Adult
Male
medicine.medical_specialty
Alkali
Ambulatory blood pressure
Hyperkalemia
030232 urology & nephrology
Urology
Renal function
030204 cardiovascular system & hematology
Kidney Function Tests
Protective Agents
Renal Agents
urologic and male genital diseases
Potassium Chloride
Young Adult
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Double-Blind Method
Potassium Citrate
medicine
Humans
Albuminuria
Renal Insufficiency, Chronic
Aged
Aged, 80 and over
Creatinine
Aldosterone
business.industry
Middle Aged
Clinical Practice: Clinical Trial Protocol
medicine.disease
Cardiovascular disease
female genital diseases and pregnancy complications
Dietary Potassium
Treatment Outcome
chemistry
Dietary Supplements
Hypertension
Potassium
Female
medicine.symptom
business
Citrate
Kidney disease
Subjects
Details
- Language :
- English
- ISSN :
- 00282766 and 16608151
- Database :
- OpenAIRE
- Journal :
- Nephron, 140(1), 48-57. KARGER, Nephron, 140(1), 48-57, Nephron, Nephron, 140(1), 48-57. Karger
- Accession number :
- edsair.doi.dedup.....3abbf0da67db08029b2c6fc9fba603b0