Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients (NCT05330663) | Clinical Trial Compass
CompletedNot Applicable
Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients
Taiwan84 participantsStarted 2020-04-08
Plain-language summary
A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.
Who can participate
Age range20 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Chronic kidney disease stage 4-5 (eGFR \<30 mL/min/1.73m2)
* Age: 20-80 years
* Patients on low protein diet (0.6-0.8 g protein/kg/d) for at least 3 months
* Written informed consent
Exclusion criteria:
* Dialysis or planned start of dialysis within next 3 months
* Patients awaiting kidney transplantation
* BMI \<18 and \>30 kg/m2
* Malnourished patients with albumin levels less than 3 g/dL who need additional supplementation of calories and nutrients
* Severe liver disease, malignant disease, infectious disease
* Existing gastrointestinal diseases or pathological findings, which do not allow EN, e.g. intestinal atony, ileus, acute upper GI bleeding, shock, or malabsorption, e.g. inflammatory bowel disease, pancreatic disease, or previous surgical GI resection
* Severely impaired gastrointestinal function, i.e. severe constipation or acute diarrhea (≥ 3 loose or watery stools per day)
* Dysphagia or high aspiration risk
* Relevant CNS and/or psychiatric disorders
* Known allergic reaction or intolerance to any of the ingredients of the study product
* Planned surgery or hospitalization during study period
* Suspicion of drug abuse
* Patients unable to follow study instructions or keeping a dietary diary
* Pregnant or lactating women
* Participation in another clinical trial with an investigational product within 30 days prior to start of study or during the study