Clinical trial NCT06892249: Suitability of Two Flavours of a High-energy, Low-protein Formula (Renalive® LP) in Chronic Kidney Disease Stage 3b-5 Outpatients in Taiwan
Official title: Suitability of Two Flavours of a High-energy, Low-protein Formula (Renalive® LP) in Chronic Kidney Disease Stage 3b-5 Outpatients in Taiwan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CKD
Low Protein Dietary Intake
Lead sponsor: Fresenius Kabi Taiwan Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 18-80 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 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.

Primary Endpoint

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

1. 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
2. Change of nutritional status using body weight, BMI, and body composition as indicators:

   * 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
3. Change of the physical performance using hand grip strength as an indicator from Baseline to Week 4
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
5. Serum albumin and pre-albumin at Baseline and Week 4
6. Blood electrolytes (sodium, potassium, phosphorus, calcium, magnesium) at Baseline, Week 2 and 4
7. Serum C-reactive protein (CRP) at Baseline, Week 2 and 4
8. Compliance rate (%) to Renalive® LP


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.

Primary outcomes:
measure: Change in body weight from Baseline to end of treatment at Week 4 (Week 4 - Baseline)
timeFrame: 4 weeks
Secondary outcomes:
measure: 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
timeFrame: 4 weeks
measure: Change in BMI from Baseline to Week 2 and Week 4
timeFrame: 4 weeks
measure: Change in body composition from Baseline to Week 4 using bioelectrical impedance assessment
timeFrame: 4 weeks
measure: Change of the physical performance using hand grip strength as an indicator from Baseline to Week 4
timeFrame: 4 weeks
measure: Change in estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) from Baseline to Week 4
timeFrame: 4 weeks
measure: Change in blood urea nitrogen and serum creatinine from Baseline to Week 2 and 4
timeFrame: 4 weeks
measure: Serum albumin and pre-albumin at Baseline and Week 4
timeFrame: 4 weeks
measure: Blood electrolytes (sodium, potassium, phosphorus, calcium, magnesium) at Baseline, Week 2 and 4
timeFrame: 4 weeks
measure: Serum C-reactive protein (CRP) at Baseline, Week 2 and 4
timeFrame: 4 weeks
measure: Compliance rate (%) to Renalive® LP
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Taipei city
country: Taiwan
facility: Taipei Tzu Chi Hospital
Study officials:
References: