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Completed

NCT Number: NCT05952544

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

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

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Active malignancy
  • Protein energy wasting
  • Advanced organ disease
  • pregnancy

Treatment and study plan

essential amino acids and keto-analogues supplementation

Drug

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

Low protein diet

Other

patients were on low protein diet only

Primary outcomes

  1. GFR decline

    Time frame: 24 months

    effect on GFR change at one year from baseline in CKD patients

Secondary outcomes

  1. effect on albumin

    Time frame: 24 months

    measurement of albumin change at one year from baseline

  2. effect on calcium

    Time frame: 24 months

    measurement of calcium change at one year from baseline

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2023
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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