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

Primary Purpose

Kidney Failure, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease Stage 3B

Status

Not yet recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Low-AGE diet

High-AGE diet

About this trial

This is an interventional prevention trial for Kidney Failure, Chronic focused on measuring kidney failure, advanced glycation products, chronic kidney disease

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Saint Joseph Saint Luc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Normal-protein and AGE-rich diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Glomerular Filtration Rate

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

Secondary Outcome Measures

Proteinuria

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

Full Information

NCT ID

NCT04827290

First Posted

March 30, 2021

Last Updated

January 3, 2022

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT04827290

Brief Title

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

Acronym

CKD AGE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2022 (Anticipated)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

Normal-protein and AGE-rich diet

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Low-AGE diet

Intervention Description

Low-AGE diet during 24 months

Intervention Type

Behavioral

Intervention Name(s)

High-AGE diet

Intervention Description

High-AGE diet during 24 months

Primary Outcome Measure Information:

Title

Glomerular Filtration Rate

Description

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

Time Frame

At 24 months

Secondary Outcome Measure Information:

Title

Proteinuria

Description

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

Time Frame

At 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fanny Doroszewski

Phone

0033478618398

fdoroszewski@chsjsl.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Gabrielle Normand, MD

lgnormand@chsjsl.fr

Facility Information:

Facility Name

Centre Hospitalier Saint Joseph Saint Luc

City

Lyon

ZIP/Postal Code

69007

Country

France

Facility Contact: