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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952544
• Other study ID #: effect of EAA/KA on GFR in CKD
• Status: Recruiting
• Start date: July 20, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: March 2024
• Source: Alexandria University
• Contact: Mohamed Mamdouh Elsayed, MD
• Phone: 00201068055103
• Email: dr_mohamedmamdouh87[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 15, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Other:
• low protein diet
patients were on low protein diet only

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Aexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GFR decline	effect on GFR change at one year from baseline in CKD patients	one year
Secondary	effect on albumin	measurement of albumin change at one year from baseline	one year
Secondary	effect on calcium	measurement of calcium change at one year from baseline	one year