Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

NCT ID: NCT05330663

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-08
• Study Completion Date: 2020-12-18

Brief Summary

A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.

Detailed Description

Previous studies indicated that low-protein formula nutritional supplements may improve compliance with an LPD and are beneficial in the management of pre-dialysis CKD patients

This study will evaluate the suitability of the disease-specific enteral formula Fresubin® renal in predialysis chronic kidney disease patients.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention group

Low protein diet with Fresubin® renal

Group Type: EXPERIMENTAL

Low protein diet with Fresubin® renal

Intervention Type: DIETARY_SUPPLEMENT

Low protein diet with Fresubin® renal Dosage: 1 bottle per day as a replacement for one regular meal. All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight.

Standard of care

Low protein diet with normal food

Group Type: OTHER

Low protein diet with normal food

Intervention Type: OTHER

All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight/day.

Interventions

Low protein diet with Fresubin® renal

Low protein diet with Fresubin® renal Dosage: 1 bottle per day as a replacement for one regular meal. All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight.

Intervention Type: DIETARY_SUPPLEMENT

Low protein diet with normal food

All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight/day.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Chronic kidney disease stage 4-5 (eGFR <30 mL/min/1.73m2)
• Age: 20-80 years
• Patients on low protein diet (0.6-0.8 g protein/kg/d) for at least 3 months
• Written informed consent

Exclusion Criteria

• Dialysis or planned start of dialysis within next 3 months
• Patients awaiting kidney transplantation
• BMI <18 and >30 kg/m2
• Malnourished patients with albumin levels less than 3 g/dL who need additional supplementation of calories and nutrients
• Severe liver disease, malignant disease, infectious disease
• Existing gastrointestinal diseases or pathological findings, which do not allow EN, e.g. intestinal atony, ileus, acute upper GI bleeding, shock, or malabsorption, e.g. inflammatory bowel disease, pancreatic disease, or previous surgical GI resection
• Severely impaired gastrointestinal function, i.e. severe constipation or acute diarrhea (≥ 3 loose or watery stools per day)
• Dysphagia or high aspiration risk
• Relevant CNS and/or psychiatric disorders
• Known allergic reaction or intolerance to any of the ingredients of the study product
• Planned surgery or hospitalization during study period
• Suspicion of drug abuse
• Patients unable to follow study instructions or keeping a dietary diary
• Pregnant or lactating women
• Participation in another clinical trial with an investigational product within 30 days prior to start of study or during the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi Taiwan Ltd.

INDUSTRY

Sponsor Role: collaborator

Taichung Veterans General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheng-Hsu Chen, MDPHD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology in Taichung Veterans General Hospital

Locations

Taichung Verterans General Hospital Taichung

Taichung, ROC, Taiwan

Countries

Taiwan

Other Identifiers

SF20045B

Identifier Type: -

Identifier Source: org_study_id