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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier le Mans

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Malnutrition or short life-expectancy

Patients aged less than 18 years old

Pregnant women,

Incapacity to complete the free-consent form,

Trial design

Design model

Parallel

Treatments tested in this trial

  • low protein diet

    Other intervention

    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).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Diet groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Adherence to the multiple-choice diet program

Percentage of patients who drop-out of the multiple choice diet program

Time frame
4 years

Secondary outcomes

1

Kidney survival

The "kidney survival" from the beginning of the diet to the start of renal replacement therapy

Time frame
4 years
2

Patient survival

The patient survival compared to reference data (from the Réseau Epidemiologie, Information, Néphrologie) and international registers.

Time frame
4 years
3

Cost of the treatment

Cost of the treatment, including diet, renal replacement therapy and pharmacological interventions.

Time frame
4 years
4

Patients included in a transplantation program

Percentage of patients without contraindications enrolled on the pre-emptive kidney transplant list.

Time frame
4 years

Other outcomes

Sponsors and contacts

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