Clinical trial NCT05952544: Effect of Protein Restriction Plus EAA/KA Supplementation on GFR Decline in CKD
Official title: Does Protein Restriction Plus Essential Amino Acids and Keto-analogues Supplementation Have a Beneficial Effect on GFR Decline in CKD Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Keywords: protein restriction
essential amino acids
ketoanalogues
GFR
CKD
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: medical records of Patients with CKD stages (G2 to G4), will be retrospectively screened from December 2021 till December 2023.

Patients will be divided into two groups:

Control group who was on low protein diet only, while the other group (interventional) consumed KA/EAA plus very low protein diet.

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.

Eligibility criteria: 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

Primary outcomes:
measure: GFR decline
timeFrame: 24 months
Secondary outcomes:
measure: effect on albumin
timeFrame: 24 months
measure: effect on calcium
timeFrame: 24 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Aexandria University
Study officials:
affiliation: lecturer
name: Mohamed Mamdouh Elsayed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: pharmacist
name: Bassant Sabry
role: STUDY_CHAIR
affiliation: pharmacist
name: Alaa Soliman
role: STUDY_CHAIR
affiliation: pharmacist
name: Mohamed A. Mekawy
role: STUDY_CHAIR
affiliation: Clinical Pharmacist
name: Engy Emam
role: STUDY_CHAIR
References:
citation: Feiten SF, Draibe SA, Watanabe R, Duenhas MR, Baxmann AC, Nerbass FB, Cuppari L. Short-term effects of a very-low-protein diet supplemented with ketoacids in nondialyzed chronic kidney disease patients. Eur J Clin Nutr. 2005 Jan;59(1):129-36. doi: 10.1038/sj.ejcn.1602050.
citation: Gao X, Huang L, Grosjean F, Esposito V, Wu J, Fu L, Hu H, Tan J, He C, Gray S, Jain MK, Zheng F, Mei C. Low-protein diet supplemented with ketoacids reduces the severity of renal disease in 5/6 nephrectomized rats: a role for KLF15. Kidney Int. 2011 May;79(9):987-96. doi: 10.1038/ki.2010.539. Epub 2011 Jan 19.
citation: Jiang Z, Zhang X, Yang L, Li Z, Qin W. Effect of restricted protein diet supplemented with keto analogues in chronic kidney disease: a systematic review and meta-analysis. Int Urol Nephrol. 2016 Mar;48(3):409-18. doi: 10.1007/s11255-015-1170-2. Epub 2015 Nov 30.
citation: Menon V, Kopple JD, Wang X, Beck GJ, Collins AJ, Kusek JW, Greene T, Levey AS, Sarnak MJ. Effect of a very low-protein diet on outcomes: long-term follow-up of the Modification of Diet in Renal Disease (MDRD) Study. Am J Kidney Dis. 2009 Feb;53(2):208-17. doi: 10.1053/j.ajkd.2008.08.009. Epub 2008 Oct 31.