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

Sponsor

Centre Hospitalier le Mans (Other)

Overall Status

Recruiting

CT.gov ID

NCT03979534

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Other: low protein diet	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 2, 2019

Anticipated Primary Completion Date :

Apr 2, 2023

Anticipated Study Completion Date :

Apr 2, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Adherence to the multiple-choice diet program [4 years]
Percentage of patients who drop-out of the multiple choice diet program

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.