To study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4 or estimated glomerular filtration rate [eGFR] 15 - 44 ml/min/1.73 m2).
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
2-year change in eGFR (renal outcome).
Secondary outcome
Effects on 24-hour blood pressure, albuminuria, cardiovascular markers, and
incidence of hyperkalemia
Background summary
Our current high-sodium, low-potassium diet lcontributes 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.
Study objective
To study the renoprotective effect of potassium supplementation in patients
with CKD (stage 3b or 4 or estimated glomerular filtration rate [eGFR] 15 - 44
ml/min/1.73 m2).
Study design
Multi-center clinical trial with open-label run-in phase (2 weeks, potassium
chloride) followed by a double-blind placebo controlled intervention study (2
years, potassium chloride vs. potassium citrate vs. placebo).
Intervention
3 x 2 capsules (or 2 x 3 capsules) containing potassium chloride (40 mmol),
potassium citrate (40 mmol) or placebo.
Study burden and risks
The study includes seven site visits with each one blood sample, 24-hour urine
collection, spot urine collection, 24-hour blood pressure measurement, and
pulse wave velocity measurement. Although these procedures are time-consuming
and may be experienced as burdensome, they are all routine clinical studies and
safe. Patients may experience a pill-burden (6 capsules/day). The open-label
run-in phase is planned as a safety step to analyze which patients will develop
hyperkalemia with potassium supplementation (they are excluded from the
subsequent phase of the study). Hyperkalemia remains a risk during the 2-year
double-blind intervention phase, but regular blood sampling and a specific
algorithm if serum potassium levels rise, should prevent this. The potential
benefits of the study are positive effects of potassium supplementation on
blood pressure and kidney function.
's Gravendijkwal 235
Rotterdam 3015 CE
NL
's Gravendijkwal 235
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Adult patients with CKD stage 3b or 4
- Fall in eGFR > 2 ml/min/1.73 m2/year in preceding years
- Hypertension (automated 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 using calcineurin inhibitors
- Patients using tolvaptan
- Kidney transplant recipients
- Patients with an active gastro-intestinal ulcus
- 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 or subjects who are deemed unfit to adequately adhere
to instructions from the research team
- Women who are pregnant, breastfeeding or consider pregnancy in the coming 2
years.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60825.078.17 |