Suitability of Two Flavours of a High-energy, Low-protein Formula (Renalive® LP) in Chronic Kidney Disease Stage 3b-5 Outpatients in Taiwan

Launched by FRESENIUS KABI TAIWAN LTD. · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the suitability of two flavors of a special high-energy, low-protein drink called Renalive® LP. This drink is designed to help people with chronic kidney disease (CKD) who are in stages 3b to 5 and need to follow a low-protein diet. The main goal is to see how this drink affects their body weight and overall nutritional status over a period of four weeks. To be eligible for this study, participants need to be between 18 and 80 years old, have CKD with specific kidney function levels, and have been following a low-protein diet for the last three months.

Participants in this trial can expect to receive the Renalive® LP drink and will need to keep track of their dietary intake and health during the study. They will have their weight, muscle strength, and kidney function checked at the beginning and end of the trial period. It’s important to note that some individuals, such as those currently receiving dialysis or with certain health conditions, will not be able to participate. This study aims to find out if this nutritional supplement can help improve the health and well-being of people living with chronic kidney disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosed with chronic kidney disease stage 3b-5 (with history of eGFR\<45 mL/min/1.73 m2)
• • 2. Age: 18-80 years
• • 3. Outpatients with instruction to keep a low protein diet (0.55-0.8 g protein /kg actual body weight/ day) in the last 3 months as evaluated by the Investigator
• • 4. Written Informed Consent from patient
• Exclusion Criteria:
• • 1. Has received dialysis or are expected to start dialysis within the next 3 months
• • 2. Patients awaiting kidney transplant
• • 3. Body mass index (BMI) \<18 kg/m2 or BMI \>30 kg/m2
• • 4. Malnourished patients with albumin \<3 g/dL in need of extra calories and nutrients
• • 5. Patients receiving or having received oral/enteral/parenteral nutrition supplementation for special medical purpose in the last 28 days
• • 6. Severe liver disease, malignant neoplastic disease, current significant infectious disease (apart from flu, cold, Hepatitis C virus (HCV) carrier, Hepatitis B virus (HBV) carrier, skin infection) deemed unsuitable for entering the trial as evaluated by the Investigator
• • 7. Existing gastrointestinal disease or pathological findings that cannot tolerate enteral nutrition or render enteral nutrition unfeasible, such as shock, acute upper gastrointestinal bleeding, intestinal sluggishness, intestinal obstruction, or malabsorption, such as inflammatory bowel disease, pancreatic disease, or gastrointestinal surgery
• • 8. Severe impairment of gastrointestinal function, i.e. severe constipation or acute diarrhoea (≥3 loose or watery stools a day)
• • 9. Swallowing difficulty or high risk of aspiration
• • 10. Central nervous system and/or certain psychiatric disorders where the patient is considered as not yet clinically stable and/or not suitable to articipate in this study by the Investigator
• • 11. Known allergic reaction or intolerance to any ingredient of the intervention formula
• • 12. Surgery or hospitalization scheduled during the trial
• • 13. Suspected drug abuse
• • 14. Unable to follow study instructions or keep a dietary diary
• • 15. Pregnant or lactating women
• • 16. Participation in other clinical trials using investigational drugs within 30 days before the start of the trial or during the trial.