Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04207203 |
Other study ID # |
ESR-18-13936 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 3, 2020 |
Est. completion date |
May 10, 2023 |
Study information
Verified date |
May 2023 |
Source |
Karolinska Institutet |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This is a descriptive single arm open-label interventional trial lasting 6 weeks aiming to
test if a low protein healthy K-rich diet with fruits, vegetables, whole grains, and nuts
with concomitant use of new potassium binder (SZC) can be safely prescribed to patients with
chronic kidney disease (CKD) stages 4 and 5 with hyperkalemia. Thirty adult CKD patients with
hyperkalemia will be included. In the first 3 weeks of the study the plasma K will be
normalized with the use of SZC and then the participants will receive a fruit basket during 3
weeks. SZC will be continued thru out the study. Primary end points will be changes in
patient satisfaction with treatment, patient symptom list, and intake of energy and protein
before and after the stabilization and healthy diet phase. Secondary outcomes will include
changes in quality of life, obstipation and circulating gut microbiota-related uremic toxins.
Description:
Feasibility, descriptive single arm open-label interventional trial lasting 6 weeks. The
study will recruit 36 CKD patients at the outpatient clinic with: age between 18 to 85 years;
glomerular filtration rate < 29 ml/min/1.73 m2 and not on dialysis; serum K > 5.1 mmol/L or
in previous use of sodium polystyrene sulfonate (SPS) to decrease serum K levels, and who
develops hyperkalemia after SPS is ceased. Patients with serum K > 6.5 mmol/ and those likely
to start dialysis within 2 months, with inflammatory bowel syndrome or with a history of
hypokalemia (<3.0 mmol/L) will not be included. Primary end points will be changes in patient
satisfaction with treatment, patient symptom list, and intake of energy and protein before
and after the stabilization and healthy diet phase. Secondary outcomes will include changes
in quality of life, obstipation and circulating gut microbiota-related uremic toxins.
Intervention: In the first 3 weeks, representing stabilization phase, SZC will be prescribed
to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day
and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed by a renal
dietitian. At the end of the first 3 weeks, the patients will be instructed to keep the diet
with same content of energy and initiate a healthy diet containing 3700 to 4000 mg/potassium
for 3 weeks (healthy diet phase). In order to increase adherence, a food basket containing
fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the
patient and the family will be provided. Serum K will be monitored to promote serum K between
3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug
label. Blood measurements, questionnaires related to quality of life and intestinal
obstipation and measurements of nutritional intake will be performed in the beginning and at
the end of the stabilization phase and again in the beginning and end of the healthy diet
phase. Additionally, during stabilization and healthy diet phases, serum K will be measured
every 72 hours until serum K is normalized and after that, once per week.