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

Chronic Kidney Diseases Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03979534
• Other study ID #: CHM-2016-S8/05
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: April 2, 2023

Study information

• Verified date: March 2022
• Source: Centre Hospitalier le Mans
• Contact: Christelle Jadeau, PD
• Phone: 0 (33) 2 43 43 43 43
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2, 2023
• Est. primary completion date: April 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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).

Locations

Country	Name	City	State
France	Centre Hospitalier Le Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

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