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Keep this study
Lead
Taichung Veterans General Hospital
With
Fresenius Kabi Taiwan Ltd.
Previous studies indicated that low-protein formula nutritional supplements may improve compliance with an LPD and are beneficial in the management of pre-dialysis CKD patients
This study will evaluate the suitability of the disease-specific enteral formula Fresubin® renal in predialysis chronic kidney disease patients.
Patients on low protein diet (0.6-0.8 g protein/kg/d) for at least 3 months
Written informed consent
You may not be if
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
Clareo Health | Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients
