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Not yet recruitingNCT04827290CKD AGEUpdated Apr 4, 2024

Assessment of the Effect of Restriction on Alimentary AGE in Progression of Chronic Kidney Disease

An interventional study of Low-AGE diet and High-AGE diet in Kidney Failure, Chronic, Chronic Kidney Disease stage3 and Chronic Kidney Disease Stage 3B, sponsored by Centre Hospitalier Saint Joseph Saint Luc de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Centre Hospitalier Saint Joseph Saint Luc de Lyon · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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

02

Conditions studied

  • 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
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 66 is close to the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon is the lead sponsor of 20 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Normal-protein and low-AGE through raw or rare proteins diet

    Normal-protein (0,8g/kg/day) and low-AGE through raw or rare proteins diet during 24 months

    Behavioral: Low-AGE diet

  • Active comparator
    Normal-protein and AGE-rich diet

    Normal-protein (0,8g/kg/day) and high-AGE through overcooked proteins diet during 24 months

    Behavioral: High-AGE diet

Interventions

  • BehavioralLow-AGE diet

    Low-AGE diet during 24 months

  • BehavioralHigh-AGE diet

    High-AGE diet during 24 months

06

What researchers measure

Primary outcomes

  1. Glomerular Filtration Rate

    Glomerular Filtration Rate estimated by the CKD-EPI formula with a blood sample

    Time frame: At 24 months

Secondary outcomes

  1. Proteinuria

    Proteinuria (g/24h) found in the 24-hour urine

    Time frame: At 24 months

07

Study locations

1 site
  • Centre Hospitalier Saint Joseph Saint Luc
    Lyon, 69007, France
    • Fanny Doroszewski · Contact · fdoroszewski@chsjsl.fr · 0033478618398
    • Gabrielle Normand, MD · Contact · lgnormand@chsjsl.fr
    • Gabrielle Normand, MD · Principal investigator
    • Emmanuel Villar, MD · Sub investigator
    • Amélie Belloi, MD · Sub investigator
    • Cecile Chauvet, MD · Sub investigator
    • Mathilde Luce, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04827290
Lead sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Aug 1, 2024 (estimated)
Primary completion
Aug 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Apr 4, 2024

Study contacts

Fanny Doroszewski
Contact
fdoroszewski@chsjsl.fr
0033478618398
Gabrielle Normand, MD
Contact
lgnormand@chsjsl.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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