Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach (ProReRePro)
Primary Purpose
Chronic Kidney Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
low protein diet
Sponsored by
About this trial
This is an interventional other trial for Chronic Kidney Diseases focused on measuring low-protein diet, pre-dialysis, chronic kidney disease, nutritional care, start of dialysis, incremental dialysis
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.
Sites / Locations
- Centre Hospitalier Le MansRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Diet group
Control group
Arm Description
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".
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.
Outcomes
Primary Outcome Measures
Adherence to the multiple-choice diet program
Percentage of patients who drop-out of the multiple choice diet program
Secondary Outcome Measures
Kidney survival
The "kidney survival" from the beginning of the diet to the start of renal replacement therapy
Patient survival
The patient survival compared to reference data (from the Réseau Epidemiologie, Information, Néphrologie) and international registers.
Cost of the treatment
Cost of the treatment, including diet, renal replacement therapy and pharmacological interventions.
Patients included in a transplantation program
Percentage of patients without contraindications enrolled on the pre-emptive kidney transplant list.
Patients included in a home dialysis program
Percentage of patients without contraindications who started a home dialysis treatment
Patients included in an incremental dialysis program.
Percentage of patients without contraindications who started dialysis with an incremental schedule.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03979534
Brief Title
Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
Acronym
ProReRePro
Official Title
Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
April 2, 2023 (Anticipated)
Study Completion Date
April 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
low-protein diet, pre-dialysis, chronic kidney disease, nutritional care, start of dialysis, incremental dialysis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diet group
Arm Type
Experimental
Arm Description
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".
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
low protein diet
Intervention Description
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).
Primary Outcome Measure Information:
Title
Adherence to the multiple-choice diet program
Description
Percentage of patients who drop-out of the multiple choice diet program
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Kidney survival
Description
The "kidney survival" from the beginning of the diet to the start of renal replacement therapy
Time Frame
4 years
Title
Patient survival
Description
The patient survival compared to reference data (from the Réseau Epidemiologie, Information, Néphrologie) and international registers.
Time Frame
4 years
Title
Cost of the treatment
Description
Cost of the treatment, including diet, renal replacement therapy and pharmacological interventions.
Time Frame
4 years
Title
Patients included in a transplantation program
Description
Percentage of patients without contraindications enrolled on the pre-emptive kidney transplant list.
Time Frame
4 years
Title
Patients included in a home dialysis program
Description
Percentage of patients without contraindications who started a home dialysis treatment
Time Frame
4 years
Title
Patients included in an incremental dialysis program.
Description
Percentage of patients without contraindications who started dialysis with an incremental schedule.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle Jadeau, PD
Phone
0 (33) 2 43 43 43 43
Ext
37 482
Email
cjadeau@ch-lemans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgina Piccoli, MD
Organizational Affiliation
Centre Hospitalier le Mans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Mans
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle Jadeau, PD
Phone
0 (33) 2 43 43 43 43
Ext
37 482
Email
cjadeau@ch-lemans.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
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