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Potassium Supplementation in CKD (K+ in CKD)

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ClinicalTrials.gov Identifier: NCT03253172
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : November 13, 2017
Dutch Kidney Foundation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Medical Center Groningen
Leiden University Medical Center
Information provided by (Responsible Party):
Ewout Hoorn, Erasmus Medical Center

Brief Summary:
The current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established. Hypertension is even more prevalent and resistant in patients with chronic kidney disease (CKD) and contributes to further decline in kidney function. Four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. All studies recommended an intervention study with potassium supplementation in patients with CKD, but this has not been performed. The aim of this study is to study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate [eGFR] 15 - 45 ml/min/1.73 m2).

Condition or disease Intervention/treatment
Renal Insufficiency, Chronic Potassium Depletion Hypertension Hyperkalemia Dietary Supplement: Potassium Chloride Dietary Supplement: Potassium Citrate Dietary Supplement: Placebo

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 532 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Renoprotective Effects of Potassium Supplementation in Chronic Kidney Disease (CKD)
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023

Arm Intervention/treatment
Placebo Comparator: Placebo
Dietary Supplement: Placebo
Experimental: Potassium Chloride
Experimental Arm 1 - Rationale is that most evidence for a positive effect of potassium comes from studies using potassium chloride
Dietary Supplement: Potassium Chloride
Two potassium supplements with varying anions.
Experimental: Potassium Citrate
Experimental Arm 2 - Rationale for citrate is that recent evidence indicates that alkali treatment may also be renoprotective.
Dietary Supplement: Potassium Citrate
Potassium Citrate

Primary Outcome Measures :
  1. Difference in estimated glomerular filtration rate (eGFR) [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. ≥ 30% decrease in eGFR [ Time Frame: Two years ]
  2. Slope analysis (change in eGFR in ml/min/1.73 m2/year) [ Time Frame: Two years ]
  3. Doubling in serum creatinine or end-stage renal disease [ Time Frame: Two years ]
  4. Progression to next CKD or albuminuria class [ Time Frame: Two years ]
  5. Ambulatory (24-hour) blood pressure [ Time Frame: Two years ]
  6. 24-hour albuminuria [ Time Frame: Two years ]
  7. Cardiovascular event [ Time Frame: Two years ]
    Coronary heart disease death, fatal myocardial infarction, fatal stroke and other cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, resuscitated cardiac arrest

  8. All-cause mortality [ Time Frame: Two years ]
  9. Incidence of hyperkalemia [ Time Frame: Two years ]
  10. NT-pro-BNP [ Time Frame: Two years ]
    Volume marker 1

  11. Bioimpedance measures [ Time Frame: Two years ]
    Volume marker 2

  12. Pulse-wave velocity [ Time Frame: Two years ]
    Cardiovascular marker 1

  13. High-sensitive CRP [ Time Frame: Two years ]
    Cardiovascular marker 2

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CKD 3b or 4 (45 - 15 ml/min/1.73 m2)
  • Δ eGFR (as estimated by the CKD-EPI equation) > 2 ml/min/1.73 m2/year (in preceding ≥ 1 year with at least 3 measurements)
  • Hypertension (defined as office blood pressure > 140/90 mmHg or use of anti-hypertensive medication)

Exclusion Criteria:

  • Hyperkalemia (serum potassium > 5.5 mmol/l) at study visit V0
  • Medical reasons to continue dual RAAS-blockade, mineralocorticoid receptor blockers, potassium-sparing diuretics, or oral potassium binders.
  • Patients with previous history of ventricular cardiac arrhythmia
  • Patients with a life expectancy < 6 months
  • Expected initiation of renal replacement therapy < 2 years
  • Incapacitated subjects
  • Women who are pregnant, breastfeeding or consider pregnancy in the coming 2 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253172

Contact: Ewout J Hoorn, MD, PhD +31107040704 e.j.hoorn@erasmusmc.nl

Academic Medical Center Amsterdam Not yet recruiting
Amsterdam, Netherlands
Contact: Liffert Vogt, MD, PhD         
University Medical Center Groningen Not yet recruiting
Groningen, Netherlands
Contact: Martin H De Borst, MD, PhD         
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands
Contact: Joris I Rotmans, MD, PhD         
Erasmus MC Recruiting
Rotterdam, Netherlands
Contact: Ewout J Hoorn    +31107040704      
Sub-Investigator: Martin Gritter, MD         
Sponsors and Collaborators
Erasmus Medical Center
Dutch Kidney Foundation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Medical Center Groningen
Leiden University Medical Center
Principal Investigator: Ewout J Hoorn, MD, PhD Erasmus Medical Center

Responsible Party: Ewout Hoorn, Coordinating PI, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03253172     History of Changes
Other Study ID Numbers: NL60825.078.17
MEC-2017-226 ( Other Identifier: ErasmusMC )
CP16.01 ( Other Grant/Funding Number: Dutch Kidney Foundation )
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Renal Insufficiency
Potassium Deficiency
Kidney Diseases
Urologic Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Deficiency Diseases
Nutrition Disorders
Citric Acid
Potassium Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Respiratory System Agents