Effect of Protein Restriction Plus EAA/KA Supplementation on GFR Decline in CKD

Last updated: August 16, 2024
Sponsor: Alexandria University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

low protein diet

essential amino acids and keto-analogues supplementation

Clinical Study ID

NCT05952544
effect of EAA/KA on GFR in CKD
  • Ages > 18
  • All Genders

Study Summary

This study aims to investigate the effect of protein restriction plus KA/EAA supplementation on GFR decline in CKD patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with CKD stages (G2 to G4), aged ≥ 18 years old

Exclusion

Exclusion Criteria:

  1. Active malignancy

  2. Protein energy wasting

  3. Advanced organ disease

  4. pregnancy

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: low protein diet
Phase:
Study Start date:
July 20, 2023
Estimated Completion Date:
May 15, 2024

Study Description

In chronic kidney disease (CKD) patients, ketoacid analogues of essential amino acids (KA/EAA) are administered to reduce the production of harmful metabolic products and enhance nutritional status. Protein restriction combined with AA supplement may have beneficial effects on CKD in several ways, by reducing nitrogen waste, oxidative stress, and inflammation, and by protecting against hemodynamic changes in glomerular hyperfiltration.

several clinical trials have documented that very low protein diets (VLPD) supplemented with KA/EAA preserve the rate of progression of advanced CKD. However, in long-term follow-up of the MDRD study, VLPD plus KA/EAA treatment did not delay progression to dialysis or transplantation.

As a result, no firm conclusions have been drawn on the effectiveness of protein-restricted diets combined with KA/EAA supplements in retarding CKD progression.

Connect with a study center

  • Faculty of Medicine, Aexandria University

    Alexandria, 21526
    Egypt

    Site Not Available

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