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

NCT ID: NCT06892249

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-04-30

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

Conditions

CKD; Low Protein Dietary Intake

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renalive® LP

Group Type: EXPERIMENTAL

Renalive® LP, flavour Vanilla

Intervention Type: DIETARY_SUPPLEMENT

flavour Vanilla

Renalive® LP, flavour Cappuccino

Intervention Type: DIETARY_SUPPLEMENT

flavour Cappuccino

Interventions

Renalive® LP, flavour Vanilla

flavour Vanilla

Intervention Type: DIETARY_SUPPLEMENT

Renalive® LP, flavour Cappuccino

flavour Cappuccino

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi Taiwan Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Tzu Chi Hospital

New Taipei City, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

Rena-001-CEN

Identifier Type: -

Identifier Source: org_study_id