Clinical trial NCT03979534: Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
Official title: Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: low-protein diet
pre-dialysis
chronic kidney disease
nutritional care
start of dialysis
incremental dialysis
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to the multiple-choice diet program
timeFrame: 4 years
Secondary outcomes:
measure: Kidney survival
timeFrame: 4 years
measure: Patient survival
timeFrame: 4 years
measure: Cost of the treatment
timeFrame: 4 years
measure: Patients included in a transplantation program
timeFrame: 4 years
measure: Patients included in a home dialysis program
timeFrame: 4 years
measure: Patients included in an incremental dialysis program.
timeFrame: 4 years
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
Study officials:
affiliation: Centre Hospitalier le Mans
name: Giorgina Piccoli, MD
role: PRINCIPAL_INVESTIGATOR
References: