Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03979534

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pôle Santé Sarthe et Loir, La Flèche, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low protein diet

Other

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 outcomes

  1. Adherence to the multiple-choice diet program

    Time frame: 4 years

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

Secondary outcomes

  1. Kidney survival

    Time frame: 4 years

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

  2. Patient survival

    Time frame: 4 years

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

  3. Cost of the treatment

    Time frame: 4 years

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

  4. Patients included in a transplantation program

    Time frame: 4 years

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

  5. Patients included in a home dialysis program

    Time frame: 4 years

    Percentage of patients without contraindications who started a home dialysis treatment

  6. Patients included in an incremental dialysis program.

    Time frame: 4 years

    Percentage of patients without contraindications who started dialysis with an incremental schedule.

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle Jadeau, PD

CONTACT

[email protected]

0 (33) 2 43 43 43 43 ext. 37 482

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: ProReRePro

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jun 7, 2019
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.