Chronic Kidney DiseasesProReReProNCT03979534
Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
A study testing low protein diet in people with Chronic Kidney Diseases, run by Centre Hospitalier le Mans at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- low protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Apr 2019to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Pôle Santé Sarthe et Loir
La Flèche, 72200
Giorgina PICCOLI, PhD, 02 44 71 30 30, gpiccoli@yahoo.it
Giorgina PICCOLI, PhD
- Recruiting
Centre Hospitalier Le Mans
Le Mans
Christelle Jadeau, PD, 0 (33) 2 43 43 43 43 ext. 37 482, cjadeau@ch-lemans.fr
Giorgina PICCOLI, PhD
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- low protein diet
- Keywords
- low-protein diet, pre-dialysis, chronic kidney disease, nutritional care, start of dialysis, incremental dialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low protein dietOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Diet group | Experimental | 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". Receives: Other: low protein diet |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the multiple-choice diet program
Percentage of patients who drop-out of the multiple choice diet program
Measured: 4 years
Secondary outcomes (6)
Kidney survival
The "kidney survival" from the beginning of the diet to the start of renal replacement therapy
Measured: 4 years
Patient survival
The patient survival compared to reference data (from the Réseau Epidemiologie, Information, Néphrologie) and international registers.
Measured: 4 years
Cost of the treatment
Cost of the treatment, including diet, renal replacement therapy and pharmacological interventions.
Measured: 4 years
Patients included in a transplantation program
Percentage of patients without contraindications enrolled on the pre-emptive kidney transplant list.
Measured: 4 years
Patients included in a home dialysis program
Percentage of patients without contraindications who started a home dialysis treatment
Measured: 4 years
Patients included in an incremental dialysis program.
Percentage of patients without contraindications who started dialysis with an incremental schedule.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgina Piccoli, MD, Principal investigator, Centre Hospitalier le Mans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979534
- Sponsor's protocol ID
- CHM-2016-S8/05
- Acronym
- ProReRePro
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
- ClinicalTrials.gov ID
- NCT03979534
- Acronym / sponsor ID
- ProReRePro / CHM-2016-S8/05
- Conditions
- Chronic Kidney Diseases
- Keywords
- low-protein diet, pre-dialysis, chronic kidney disease, nutritional care, start of dialysis, incremental dialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet group | Experimental | Other: low protein dietDiet 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". |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low protein dietPatients 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). | Other | Diet group |
Primary outcome
Adherence to the multiple-choice diet program
Time frame: 4 years
Percentage of patients who drop-out of the multiple choice diet program
6 secondary outcomes
Kidney survival
Time frame: 4 years
Patient survival
Time frame: 4 years
Cost of the treatment
Time frame: 4 years
Patients included in a transplantation program
Time frame: 4 years
Patients included in a home dialysis program
Time frame: 4 years
Patients included in an incremental dialysis program.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giorgina Piccoli, MD principal investigator
Centre Hospitalier le Mans
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low protein diet in people with Chronic Kidney Diseases, run by Centre Hospitalier le Mans at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle Jadeau, PD (0 (33) 2 43 43 43 43 ext. 37 482, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the multiple-choice diet program (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.