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

NCT06892249 | Completed

• 1 other identifier: Rena-001-CEN
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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 outpatients Inclusion criteria (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. Exclusion criteria

• Change in body weight from Baseline to Week 2
• Change in BMI from Baseline to Week 2 and week 4
• Change in body composition from Baseline to Week 4 using bioelectrical impedance assessment
• Change of the physical performance using hand grip strength as an indicator from Baseline to Week 4
• Change of renal function:
• Change in estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) from Baseline to Week 4
• Change in blood urea nitrogen and serum creatinine from Baseline to Week 2 and 4
• Serum albumin and pre-albumin at Baseline and Week 4
• Blood electrolytes (sodium, potassium, phosphorus, calcium, magnesium) at Baseline, Week 2 and 4
• Serum C-reactive protein (CRP) at Baseline, Week 2 and 4
• Compliance rate (%) to Renalive® LP

Conditions

CKD; Low Protein Dietary Intake; Malnutrition (Calorie)

Outcome Measures

Primary Outcomes (1)

• Change in body weight from Baseline to end of treatment at Week 4 (Week 4 - Baseline)

  4 weeks

Secondary Outcomes (10)

• Daily dietary intake of energy, protein, sodium, potassium, magnesium, phosphorus, and calcium at Baseline, Week 2 and 4 based on a 3-Day Dietary Record

  4 weeks

• Change in BMI from Baseline to Week 2 and Week 4

  4 weeks

• Change in body composition from Baseline to Week 4 using bioelectrical impedance assessment

  4 weeks

• Change of the physical performance using hand grip strength as an indicator from Baseline to Week 4

  4 weeks

• Change in estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) from Baseline to Week 4

  4 weeks

Study Arms (1)

Renalive® LP

EXPERIMENTAL

Dietary Supplement: Renalive® LP, flavour Vanilla; Dietary Supplement: Renalive® LP, flavour Cappuccino

Interventions

Renalive® LP, flavour Vanilla DIETARY_SUPPLEMENT

flavour Vanilla

Renalive® LP

Renalive® LP, flavour Cappuccino DIETARY_SUPPLEMENT

flavour Cappuccino

Renalive® LP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with chronic kidney disease stage 3b-5 (with history of eGFR\<45 mL/min/1.73 m2)
• Age: ≥18 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

You may not qualify if:

• 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 7 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

Sponsors & Collaborators

• Fresenius Kabi Taiwan Ltd.: lead

Study Sites (2)

Kaosiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Taipei TzuChi Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 24, 2025
• Study Start: June 4, 2025
• Primary Completion: April 21, 2026
• Study Completion: April 21, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

TW (2)