Clareo Health | Suitability of Two Flavours of a High-energy, Low-protein Formula (Renalive® LP) in Chronic Kidney Disease Stage 3b-5 Outpatients in Taiwan
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fresenius Kabi Taiwan Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Diagnosed with chronic kidney disease stage 3b-5 (with history of eGFR\<45 mL/min/1.73 m2)
2. Age: ≥18 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
You may not be if
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 7 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 participate 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.
