Status:
COMPLETED
Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients
Lead Sponsor:
Taichung Veterans General Hospital
Collaborating Sponsors:
Fresenius Kabi Taiwan Ltd.
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.
Detailed Description
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 evalua...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2020
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05330663
Start Date
April 8 2020
End Date
December 18 2020
Last Update
April 15 2022
Active Locations (1)
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1
Taichung Verterans General Hospital Taichung
Taichung, ROC, Taiwan, 40705