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

April 3, 2024 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69007
        • Centre Hospitalier Saint Joseph Saint Luc
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabrielle Normand, MD
        • Sub-Investigator:
          • Emmanuel Villar, MD
        • Sub-Investigator:
          • Cecile Chauvet, MD
        • Sub-Investigator:
          • Mathilde Luce, MD
        • Sub-Investigator:
          • Amélie Belloi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Low-AGE diet during 24 months
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
High-AGE diet during 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular Filtration Rate
Time Frame: At 24 months
Glomerular Filtration Rate estimated by the CKD-EPI formula with a blood sample
At 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteinuria
Time Frame: At 24 months
Proteinuria (g/24h) found in the 24-hour urine
At 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKD AGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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