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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: low protein diet

Detailed Description

The recent paradigm on dialysis start suggests that an intention to defer policy should be preferred to beginning dialysis early ("the earliest the best" strategy). This strategy is further supported by the consideration that patient profiles are changing with the increasing proportion of older and higher comorbidity patients. In high comorbidity patients, survival is not necessarily improved by dialysis.

Nutritional care, adapted to each patient's needs and preferences, could in part answer these demands. Indeed, renal function has a strict correlation with dietary patterns. Low protein diets may have two favourable effects: 1) slowing down kidney function decline and 2) delaying the need of replacement therapy (metabolic stabilizing). In dialysis, the nutritional state is the most important survival indicator, and nutritional follow-up should allow starting dialysis in a good nutritional status.

The study proposed here is an implementation study with a principal aim to improve the use of low protein diets in the clinical setting, by offering a multiple choice approach and by adapting the diets to the patients' needs.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle Jadeau, PD; Phone Number: 37 482 0 (33) 2 43 43 43 43; Email: cjadeau@ch-lemans.fr

Study Locations

• France
  • Le Mans, France
    • Recruiting
    • Centre Hospitalier Le Mans
    • Contact: Christelle Jadeau, PD; Phone Number: 37 482 0 (33) 2 43 43 43 43; Email: cjadeau@ch-lemans.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Diet group; 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; 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).
NO_INTERVENTION: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the multiple-choice diet program	Percentage of patients who drop-out of the multiple choice diet program	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney survival	The "kidney survival" from the beginning of the diet to the start of renal replacement therapy	4 years
Patient survival	The patient survival compared to reference data (from the Réseau Epidemiologie, Information, Néphrologie) and international registers.	4 years
Cost of the treatment	Cost of the treatment, including diet, renal replacement therapy and pharmacological interventions.	4 years
Patients included in a transplantation program	Percentage of patients without contraindications enrolled on the pre-emptive kidney transplant list.	4 years
Patients included in a home dialysis program	Percentage of patients without contraindications who started a home dialysis treatment	4 years
Patients included in an incremental dialysis program.	Percentage of patients without contraindications who started dialysis with an incremental schedule.	4 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans
• Investigators: Principal Investigator: Giorgina Piccoli, MD, Centre Hospitalier Le Mans

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2019
• Primary Completion (ANTICIPATED): April 2, 2023
• Study Completion (ANTICIPATED): April 2, 2023

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (ACTUAL): June 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: chronic kidney disease; low-protein diet; pre-dialysis; nutritional care; start of dialysis; incremental dialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: CHM-2016-S8/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No