Kidney Failure, ChronicCKD AGENCT04827290
Assessment of the Effect of Restriction on Alimentary AGE in Progression of Chronic Kidney Disease
A study testing Low-AGE diet and High-AGE diet in people with Kidney Failure, Chronic and Chronic Kidney Disease stage3, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
Trial summary
Normal-protein and low-AGE through raw or rare proteins diet versus normal-protein and high-AGE diet in stage IIIa-b renal failure patients Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Kidney Failure, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease Stage 3B
- What is being tested?
- Low-AGE diet and High-AGE diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a grade IIIA-B CKD (GFR with CKD-EPI ≥ 30 mL/min and < 60mL/min)
- Informed consent signed
- Aged 18 to 89 years
Who cannot join
- Protected adult
- Acute renal failure
- Patient already on a low-AGE diet (< 1kU AGE/day) following a dietetic consultation
- Current participation in another interventional research
Trial locations and contacts
1 site in 1 country.
Gabrielle Normand, MD contact
France1 site
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007
Fanny Doroszewski, 0033478618398, fdoroszewski@chsjsl.fr
Gabrielle Normand, MD, lgnormand@chsjsl.fr
About this study
Official title: Assessment of the Effect of Restriction on Alimentary AGE (Advanced Glycation Products) in Progression of Chronic Kidney Disease (CKD)
Normal-protein and low-AGE through raw or rare proteins diet versus normal-protein and high-AGE diet in stage IIIa-b renal failure patients
- Conditions
- Kidney Failure, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease Stage 3A (Disorder), Chronic Kidney Disease, Stage 3 (Moderate), Diet Habit
- Being tested
- Low-AGE diet, High-AGE diet
- Keywords
- kidney failure, advanced glycation products, chronic kidney disease
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Lymphoma, Follicular, Feeding Behavior, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-AGE dietBehavioural
Low-AGE diet during 24 months
High-AGE dietBehavioural
High-AGE diet during 24 months
| Study group | Role | What they receive |
|---|---|---|
| Normal-protein and low-AGE through raw or rare proteins diet | Experimental | Normal-protein (0,8g/kg/day) and low-AGE through raw or rare proteins diet during 24 months Receives: Behavioral: Low-AGE diet |
| Normal-protein and AGE-rich diet | Active comparator | Normal-protein (0,8g/kg/day) and high-AGE through overcooked proteins diet during 24 months Receives: Behavioral: High-AGE diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate
Glomerular Filtration Rate estimated by the CKD-EPI formula with a blood sample
Measured: At 24 months
Secondary outcomes (1)
Proteinuria
Proteinuria (g/24h) found in the 24-hour urine
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827290
- Sponsor's protocol ID
- CKD AGE
- Acronym
- CKD AGE
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2021
- Last updated
- 4 Apr 2024
- 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Restriction on Alimentary AGE (Advanced Glycation Products) in Progression of Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT04827290
- Acronym / sponsor ID
- CKD AGE / CKD AGE
- Conditions
- Kidney Failure, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease Stage 3A (Disorder), Chronic Kidney Disease, Stage 3 (Moderate), Diet Habit
- Keywords
- kidney failure, advanced glycation products, chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 1 Apr 2021 (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.
Normal-protein and low-AGE through raw or rare proteins diet versus normal-protein and high-AGE diet in stage IIIa-b renal failure patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal-protein and low-AGE through raw or rare proteins diet | Experimental | Behavioral: Low-AGE dietNormal-protein (0,8g/kg/day) and low-AGE through raw or rare proteins diet during 24 months |
| Normal-protein and AGE-rich diet | Active comparator | Behavioral: High-AGE dietNormal-protein (0,8g/kg/day) and high-AGE through overcooked proteins diet during 24 months |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a grade IIIA-B CKD (GFR with CKD-EPI ≥ 30 mL/min and < 60mL/min)
- Informed consent signed
- Aged 18 to 89 years
Key exclusion criteria (4 listed)
- Protected adult
- Acute renal failure
- Patient already on a low-AGE diet (< 1kU AGE/day) following a dietetic consultation
- Current participation in another interventional research
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-AGE dietLow-AGE diet during 24 months | Behavioural | Normal-protein and low-AGE through raw or rare proteins diet |
| High-AGE dietHigh-AGE diet during 24 months | Behavioural | Normal-protein and AGE-rich diet |
Primary outcome
Glomerular Filtration Rate
Time frame: At 24 months
Glomerular Filtration Rate estimated by the CKD-EPI formula with a blood sample
1 secondary outcome
Proteinuria
Time frame: At 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- 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. This study is not recruiting at the moment.
Gabrielle Normand, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-AGE diet and High-AGE diet in people with Kidney Failure, Chronic and Chronic Kidney Disease stage3, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fanny Doroszewski (0033478618398, fdoroszewski@chsjsl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular Filtration Rate (time frame: At 24 months). 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 4 Apr 2024.