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

Does Protein Restriction Plus Essential Amino Acids and Keto-analogues Supplementation Have a Beneficial Effect on GFR Decline in CKD Patients?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05952544

Enrollment

400

Registered

2023-07-19

Start date

2023-07-20

Completion date

2024-05-15

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

protein restriction, essential amino acids, ketoanalogues, GFR, CKD

Brief summary

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

Detailed 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.

Interventions

DRUGessential amino acids and keto-analogues supplementation

very low protein diet plus essential amino acids and keto-analogues supplementation

OTHERlow protein diet

patients were on low protein diet only

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

1. Active malignancy 2. Protein energy wasting 3. Advanced organ disease 4. pregnancy

Design outcomes

Primary

Measure	Time frame	Description
GFR decline	24 months	effect on GFR change at one year from baseline in CKD patients

Secondary

Measure	Time frame	Description
effect on albumin	24 months	measurement of albumin change at one year from baseline
effect on calcium	24 months	measurement of calcium change at one year from baseline

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026