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| ID | Type | Description | Link |
|---|---|---|---|
| MEC-2017-226 | Other Identifier | ErasmusMC | |
| CP16.01 | Other Grant/Funding Number | Dutch Kidney Foundation |
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| Name | Class |
|---|---|
| Dutch Kidney Foundation | OTHER |
| University Medical Center Groningen | OTHER |
| Leiden University Medical Center | OTHER |
| Amsterdam UMC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Potassium Chloride | Experimental | Experimental Arm 1 - Rationale is that most evidence for a positive effect of potassium comes from studies using potassium chloride |
|
| Potassium Citrate | Experimental | Experimental Arm 2 - Rationale for citrate is that recent evidence indicates that alkali treatment may also be renoprotective. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Chloride | Dietary Supplement | Two potassium supplements with varying anions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in estimated glomerular filtration rate (eGFR) | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| ≥ 30% decrease in eGFR | Two years | |
| Slope analysis (change in eGFR in ml/min/1.73 m2/year) | Two years | |
| Doubling in serum creatinine or end-stage renal disease |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of 2-week KCl supplementation on plasma potassium (mmol/l) | Run-in outcome 1 | Two weeks |
| Incidence of Hyperkalemia after 2-week KCl supplementation | Run-in outcome 2 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ewout J Hoorn, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center Amsterdam | Amsterdam | Netherlands | ||||
| University Medical Center Groningen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40779318 | Derived | Sunga CGG, Zelnick LR, Bansal N. Urinary Sodium and Potassium Excretion and the Risk of Cardiovascular Events in CKD. Kidney360. 2026 Jan 1;7(1):94-106. doi: 10.34067/KID.0000000943. Epub 2025 Aug 8. | |
| 35609996 | Derived | Gritter M, Wouda RD, Yeung SMH, Wieers MLA, Geurts F, de Ridder MAJ, Ramakers CRB, Vogt L, de Borst MH, Rotmans JI, Hoorn EJ; on behalf of K onsortium. Effects of Short-Term Potassium Chloride Supplementation in Patients with CKD. J Am Soc Nephrol. 2022 Sep;33(9):1779-1789. doi: 10.1681/ASN.2022020147. Epub 2022 May 24. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007008 | Hypokalemia |
| D006973 | Hypertension |
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D011189 | Potassium Chloride |
| D019357 | Potassium Citrate |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| OTHER |
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| Potassium Citrate | Dietary Supplement | Potassium Citrate |
|
| Placebo | Dietary Supplement | Placebo |
|
| Two years |
| Progression to next CKD or albuminuria class | Two years |
| Ambulatory (24-hour) blood pressure | Two years |
| 24-hour albuminuria | Two years |
| Cardiovascular event | 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 | Two years |
| All-cause mortality | Two years |
| Incidence of hyperkalemia | Two years |
| NT-pro-BNP | Volume marker 1 | Two years |
| Bioimpedance measures | Volume marker 2 | Two years |
| Pulse-wave velocity | Cardiovascular marker 1 | Two years |
| High-sensitive CRP | Cardiovascular marker 2 | Two years |
| Two weeks |
| Effects of 2-week KCl supplementation on office blood pressure (mmHg) | Run-in outcome 3 | Two weeks |
| Groningen |
| Netherlands |
| Leiden University Medical Center | Leiden | Netherlands |
| Erasmus MC | Rotterdam | Netherlands |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017680 |
| Potassium Compounds |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |