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Renal Insufficiency, ChronicK+ in CKDNCT03253172

Potassium Supplementation in CKD

A study testing Potassium Chloride and Potassium Citrate in people with Renal Insufficiency, Chronic and Potassium Depletion, run by Erasmus Medical Center at 4 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Potassium Chloride and Potassium Citrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
532 participants
Where
4 sitesNetherlands
Study dates
1 Jul 2017to 1 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Academic Medical Center Amsterdam

    Amsterdam

  • University Medical Center Groningen

    Groningen

  • Leiden University Medical Center

    Leiden

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

About this study

Official title: Renoprotective Effects of Potassium Supplementation in Chronic Kidney Disease (CKD)

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).

Being tested
Potassium Chloride, Potassium Citrate, Placebo
Medical subject headings
Renal Insufficiency, Chronic, Hypokalemia, Hypertension, Hyperkalemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Potassium ChlorideDietary supplement

    Two potassium supplements with varying anions.

  • Potassium CitrateDietary supplement

    Potassium Citrate

  • PlaceboDietary supplement

    Placebo

Study groups in NCT03253172
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Dietary Supplement: Placebo
Potassium ChlorideExperimentalExperimental Arm 1 - Rationale is that most evidence for a positive effect of potassium comes from studies using potassium chloride
Receives: Dietary Supplement: Potassium Chloride
Potassium CitrateExperimentalExperimental Arm 2 - Rationale for citrate is that recent evidence indicates that alkali treatment may also be renoprotective.
Receives: Dietary Supplement: Potassium Citrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in estimated glomerular filtration rate (eGFR)

    Measured: Two years

Secondary outcomes (13)

  1. ≥ 30% decrease in eGFR

    Measured: Two years

  2. Slope analysis (change in eGFR in ml/min/1.73 m2/year)

    Measured: Two years

  3. Doubling in serum creatinine or kidney failure (CKD stage 5 or start of kidney replacement therapy)

    Measured: Two years

  4. Progression to next CKD or albuminuria class

    Measured: Two years

  5. Ambulatory (24-hour) blood pressure

    Measured: Two years

  6. Spot urine albumin to creatinine ratio (UACR)

    Measured: Two years

  7. 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

    Measured: Two years

  8. All-cause mortality

    Measured: Two years

  9. Incidence of hyperkalemia

    Measured: Two years

  10. NT-pro-BNP

    Volume marker 1

    Measured: Two years

  11. Bioimpedance measures

    Volume marker 2

    Measured: Two years

  12. Pulse-wave velocity

    Cardiovascular marker 1

    Measured: Two years

  13. High-sensitive CRP

    Cardiovascular marker 2

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2017
  2. Study start1 Jul 2017
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
532 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03253172
Sponsor's protocol ID
NL60825.078.17/NL-008786
Other IDs
CP16.01, MEC-2017-226
Acronym
K+ in CKD
Status last verified
Aug 2026
First submitted
15 Aug 2017
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40779318

  • 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.

    PubMed 35609996

Questions about this trial

What is this clinical trial studying?

A study testing Potassium Chloride and Potassium Citrate in people with Renal Insufficiency, Chronic and Potassium Depletion, run by Erasmus Medical Center at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in estimated glomerular filtration rate (eGFR) (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03253172, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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