Chronic Kidney DiseasesNCT05952544
Effect of Protein Restriction Plus EAA/KA Supplementation on GFR Decline in CKD
An observational study of Chronic Kidney Diseases, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aims to investigate the effect of protein restriction plus KA/EAA supplementation on GFR decline in CKD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- essential amino acids and keto-analogues supplementation and low protein diet
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2023to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with CKD stages (G2 to G4), aged ≥ 18 years old
Who cannot join
- Active malignancy
- Protein energy wasting
- Advanced organ disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Protein Restriction Plus Essential Amino Acids and Keto-analogues Supplementation Have a Beneficial Effect on GFR Decline in CKD Patients?
This study aims to investigate the effect of protein restriction plus KA/EAA supplementation on GFR decline in CKD patients.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- essential amino acids and keto-analogues supplementation, low protein diet
- Keywords
- protein restriction, essential amino acids, ketoanalogues, GFR, CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
essential amino acids and keto-analogues supplementationDrug
very low protein diet plus essential amino acids and keto-analogues supplementation
low protein dietOther
patients were on low protein diet only
| Study group | Role | What they receive |
|---|---|---|
| control group | include patients who were on low protein diet only Receives: Other: low protein diet | |
| interventional group | include patients who consumed KA/EAA plus very low protein diet Receives: Drug: essential amino acids and keto-analogues supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR decline
effect on GFR change at one year from baseline in CKD patients
Measured: 24 months
Secondary outcomes (2)
effect on albumin
measurement of albumin change at one year from baseline
Measured: 24 months
effect on calcium
measurement of calcium change at one year from baseline
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start20 Jul 2023
- Primary completion30 Mar 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- Mohamed Mamdouh Elsayed, MD, Principal investigator, lecturerBassant Sabry, Study chair, pharmacistAlaa Soliman, Study chair, pharmacistMohamed A. Mekawy, Study chair, pharmacistEngy Emam, Study chair, Clinical Pharmacist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952544
- Sponsor's protocol ID
- effect of EAA/KA on GFR in CKD
- Status last verified
- Aug 2024
- First submitted
- 1 Jul 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15354199Gao 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.
PubMed 21248717Jiang 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.
PubMed 26620578Menon 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.
PubMed 18950911
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Protein Restriction Plus Essential Amino Acids and Keto-analogues Supplementation Have a Beneficial Effect on GFR Decline in CKD Patients?
- ClinicalTrials.gov ID
- NCT05952544
- Acronym / sponsor ID
- effect of EAA/KA on GFR in CKD
- Conditions
- Chronic Kidney Diseases
- Keywords
- protein restriction, essential amino acids, ketoanalogues, GFR, CKD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: low protein dietinclude patients who were on low protein diet only |
| interventional group | – | Drug: essential amino acids and keto-analogues supplementationinclude patients who consumed KA/EAA plus very low protein diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with CKD stages (G2 to G4), aged ≥ 18 years old
Key exclusion criteria (4 listed)
- Active malignancy
- Protein energy wasting
- Advanced organ disease
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| essential amino acids and keto-analogues supplementationvery low protein diet plus essential amino acids and keto-analogues supplementation | Drug | interventional group |
| low protein dietpatients were on low protein diet only | Other | control group |
Primary outcome
GFR decline
Time frame: 24 months
effect on GFR change at one year from baseline in CKD patients
2 secondary outcomes
effect on albumin
Time frame: 24 months
effect on calcium
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Background: PubMed 15354199Feiten 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.
- Background: PubMed 21248717Gao 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.
- Background: PubMed 26620578Jiang 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.
- Background: PubMed 18950911Menon 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Mamdouh Elsayed, MD principal investigator
lecturer
Bassant Sabry study chair
pharmacist
Alaa Soliman study chair
pharmacist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GFR decline (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05952544, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.