Status:
NOT_YET_RECRUITING
Suitability of Two Flavours of a High-energy, Low-protein Formula (Renalive® LP) in Chronic Kidney Disease Stage 3b-5 Outpatients in Taiwan
Lead Sponsor:
Fresenius Kabi Taiwan Ltd.
Conditions:
CKD
Low Protein Dietary Intake
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Purpose of study To evaluate suitability of two flavours of a high energy low protein formula (Renalive® LP) as oral nutritional supplement and meal replacement in chronic kidney disease stage 3b-5 ou...
Eligibility Criteria
Inclusion
- Diagnosed with chronic kidney disease stage 3b-5 (with history of eGFR\<45 mL/min/1.73 m2)
- Age: 18-80 years
- 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
- Written Informed Consent from patient
Exclusion
- Has received dialysis or are expected to start dialysis within the next 3 months
- Patients awaiting kidney transplant
- Body mass index (BMI) \<18 kg/m2 or BMI \>30 kg/m2
- Malnourished patients with albumin \<3 g/dL in need of extra calories and nutrients
- Patients receiving or having received oral/enteral/parenteral nutrition supplementation for special medical purpose in the last 28 days
- 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
- 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
- Severe impairment of gastrointestinal function, i.e. severe constipation or acute diarrhoea (≥3 loose or watery stools a day)
- Swallowing difficulty or high risk of aspiration
- 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
- Known allergic reaction or intolerance to any ingredient of the intervention formula
- Surgery or hospitalization scheduled during the trial
- Suspected drug abuse
- Unable to follow study instructions or keep a dietary diary
- Pregnant or lactating women
- Participation in other clinical trials using investigational drugs within 30 days before the start of the trial or during the trial.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06892249
Start Date
May 1 2025
End Date
April 30 2026
Last Update
March 24 2025
Active Locations (1)
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1
Taipei Tzu Chi Hospital
New Taipei City, Taiwan, Taiwan, 231016