Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach

NCT03979534 | Unknown

• 1 other identifier: CHM-2016-S8/05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Nephrology care continues to progress and recommendations are now focused on delaying as much as possible the need for renal replacement therapy ("intent-to-defer"strategy). Protein restriction is a valuable tool for stabilizing chronic kidney disease (CKD) and retarding the need for renal replacement therapy, but the best diet to be prescribed is still matter of discussion. This study is aimed at identifying implementation strategies for nutritional management of advanced CKD.

Conditions

Chronic Kidney Diseases

Keywords

low-protein diet; pre-dialysis; chronic kidney disease; nutritional care; start of dialysis; incremental dialysis

Outcome Measures

Primary Outcomes (1)

• Adherence to the multiple-choice diet program

  Percentage of patients who drop-out of the multiple choice diet program

  4 years

Secondary Outcomes (6)

• Kidney survival

  4 years

• Patient survival

  4 years

• Cost of the treatment

  4 years

• Patients included in a transplantation program

  4 years

• Patients included in a home dialysis program

  4 years

Study Arms (2)

Diet group

EXPERIMENTAL

Diet follow-up to personalize a low-protein diet for each patient. All patients following a low protein diet one month or more compose the "diet group".

Other: low protein diet

Control group

NO INTERVENTION

Patients who accepted to take part of the study but refused the low protein diet and patients who discontinued the diet on the first month compose the control group.

Interventions

low protein diet OTHER

Patients will be managed with a restricted protein intake (controlled protein diets with a mean target at 0.6 g / kg / day of protein, according to a choice of dietary approaches, adapted to the situation of each patient).

Diet group

Eligibility Criteria

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

You may qualify if:

• All adult patients followed on the unit for advanced CKD, with Kidney disease stage 4-5 or stage 3 with fast progression and without contraindications.

You may not qualify if:

• Malnutrition or short life-expectancy
• Patients aged less than 18 years old
• Pregnant women,
• Incapacity to complete the free-consent form,
• Pateints refusing participation in the study,
• Patients without healthcare coverage.

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Le Mans

Le Mans, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Giorgina Piccoli, MD

  Centre Hospitalier le Mans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christelle Jadeau, PD

CONTACT

0 (33) 2 43 43 43 43; cjadeau@ch-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 7, 2019
• Study Start: April 2, 2019
• Primary Completion: April 2, 2023
• Study Completion: April 2, 2023
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)