Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study

Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi). Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium \> 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Chronic Kidney disease, stage 3 to 4b (eGFR 44-15 ml/min/1.73m\^2)

• Use of inhibitor of the renin-angiotensin system

Locations
Other Locations
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Contact Information
Primary
Joris I Rotmans, Professor
j.i.rotmans@lumc.nl
+31 71 5292148
Backup
Wouter T Moest, MD
w.t.moest@lumc.nl
+31 71 5292148
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 16
Treatments
Experimental: Potassium enriched diet
Patients with chronic kidney disease stage 3b to 4 will be treated for 6 weeks with a potassium enriched diet (adding +40mmol/day in the form of fruits/vegetables/nuts)
No_intervention: Regular diet
Patients with chronic kidney disease stage 3b to 4 will followed for 6 weeks, during their regular diet
Sponsors
Leads: Leiden University Medical Center
Collaborators: AstraZeneca

This content was sourced from clinicaltrials.gov