Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Kidney Diseases

Keywords

protein restrictionessential amino acidsketoanaloguesGFRCKD

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

effect on albumin
24 months
effect on calcium
24 months

Study Arms (2)

control group

include patients who were on low protein diet only

Other: low protein diet

interventional group

include patients who consumed KA/EAA plus very low protein diet

Drug: essential amino acids and keto-analogues supplementation

Interventions

essential amino acids and keto-analogues supplementationDrug

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

interventional group

low protein dietOther

patients were on low protein diet only

control group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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.

You may qualify if:

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

Sponsors & Collaborators

Alexandria University
Otherlead

Study Sites (1)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

Related 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.
PMID: 15354199BACKGROUND
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.
PMID: 21248717BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Amino Acids, EssentialDiet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Mohamed Mamdouh Elsayed, MD
lecturer
PRINCIPAL INVESTIGATOR
Bassant Sabry
pharmacist
STUDY CHAIR
Alaa Soliman
pharmacist
STUDY CHAIR
Mohamed A. Mekawy
pharmacist
STUDY CHAIR

Enrollment

400 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Lecturer

Study Record Dates

First Submitted

July 1, 2023

First Posted

July 19, 2023

Study Start

July 20, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

control group

interventional group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

control group

interventional group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations