CKDNCT06670599
Neutrophil-to-Lymphocyte and Platelet-to-lymphocyte Ratios as a Predictor Factors for Chronic Kidney Disease Progression
An observational study of CKD, run by Assiut University.
Trial summary
In this study, we aim to investigate whether NLR and PLR levels are associated with decline of kidney function in patients with CKD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- CKD
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2024to 10 Nov 2025
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Prevalence of Chronic Kidney disease (CKD) in 2017 was 7.1 million individuals globally and in Egypt was 106 patients per 1000 population estimated by (GBD) the Global Burden of Disease. In September 2021, about 10% of adult population is estimated to have CKD in the world, but the prevalence is higher in Egypt accounted for about 15-20% of adults.
Who may be able to join
- 200 Patients diagnosed with CKD and their age range between 18-65 years old who will be admitted at AUH.
Who cannot join
- Pediatric patients aged below< 18 or elderly patients aged above 65.
- Pregnant females.
- Patients with Diabetes Mellitus.
- Acute kidney injury (AKI).
- Patients with current infections.
- Patients who have any type of malignancy.
- Patients who have any type of multi-organ failure.
- CKD patients on dialysis
Trial locations and contacts
No sites are listed yet.
About this study
In this study, we aim to investigate whether NLR and PLR levels are associated with decline of kidney function in patients with CKD.
Read the detailed description
Chronic inflammation is closely associated with various chronic diseases, such as diabetes mellitus, cardiovascular disease, and chronic kidney disease (CKD) (1). Patients with CKD tend to have elevated levels of inflammatory mediators, including high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF alpha), and interleukin (IL)-6 (2).These mediators stimulate inflammatory pathway, leading to glomerular hypertension, tubulointerstitial fibrosis, kidney scarring, and, finally, CKD progression and increased cardiovascular events (3,4). Therefore, it is important to evaluate and decrease the extent of chronic inflammation in patients with CKD. Patients with CKD have higher levels of proinflammatory cytokines, but it remains unclear which biomarker is the best indicator of inflammation in patients with CKD.
The neutrophil-to-lymphocyte ratio (NLR), obtained by dividing the absolute number of neutrophils to the lymphocyte count, is increasingly studied as a new inflammatory marker. An elevated NLR has recently been reported to be an independent predictor of mortality in patients with cardiovascular disease or cancer [5-8]. As CKD is a chronic inflammatory disease, high NLR can predict CKD progression, cardiovascular disease and cancer. However, significantly few studies have investigated the association between high NLR and CKD progression [9-12].
Platelet-to-lymphocyte ratio (PLR) has recently been recognized as a novel inflammatory marker and has been shown to be associated with the prognosis in CKD patients [13].
In 2012, Kidney Disease: Improving Global Outcome (KDIGO) classified CKD in six categories by GFR estimation (in mL/min/1.73 m2).
- Conditions
- CKD
- Keywords
- NLR & PLR in CKD
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between NLR, PLR and severity of CKD.
Correlation between NLR, PLR and severity of CKD.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion10 Nov 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Said Ashamallah Said, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670599
- Sponsor's protocol ID
- NLR & PLR in CKD.
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gan W, Guan Q, Hu X, Zeng X, Shao D, Xu L, Xiao W, Mao H, Chen W. The association between platelet-lymphocyte ratio and the risk of all-cause mortality in chronic kidney disease: a systematic review and meta-analysis. Int Urol Nephrol. 2022 Nov;54(11):2959-2967. doi: 10.1007/s11255-022-03234-0. Epub 2022 May 17.
PubMed 35581444Altunoren O, Akkus G, Sezal DT, Ciftcioglu M, Guzel FB, Isiktas S, Torun GI, Uyan M, Sokmen MF, Sevim HA, Sarisik FN, Senel ME, Erken E, Gungor O. Does neutrophyl to lymphocyte ratio really predict chronic kidney disease progression? Int Urol Nephrol. 2019 Jan;51(1):129-137. doi: 10.1007/s11255-018-1994-7. Epub 2018 Oct 1.
PubMed 30276600Navarro JF, Milena FJ, Mora C, Leon C, Garcia J. Renal pro-inflammatory cytokine gene expression in diabetic nephropathy: effect of angiotensin-converting enzyme inhibition and pentoxifylline administration. Am J Nephrol. 2006;26(6):562-70. doi: 10.1159/000098004. Epub 2006 Dec 13.
PubMed 17167242Turkmen K, Guney I, Yerlikaya FH, Tonbul HZ. The relationship between neutrophil-to-lymphocyte ratio and inflammation in end-stage renal disease patients. Ren Fail. 2012;34(2):155-9. doi: 10.3109/0886022X.2011.641514. Epub 2011 Dec 16.
PubMed 22172001Manabe I. Chronic inflammation links cardiovascular, metabolic and renal diseases. Circ J. 2011;75(12):2739-48. doi: 10.1253/circj.cj-11-1184. Epub 2011 Nov 8.
PubMed 22067929
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil-to-Lymphocyte and Platelet-to-lymphocyte Ratios as a Predictor Factors for Chronic Kidney Disease Progression
- ClinicalTrials.gov ID
- NCT06670599
- Acronym / sponsor ID
- NLR & PLR in CKD.
- Conditions
- CKD
- Keywords
- NLR & PLR in CKD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 1 Nov 2024 (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.
In this study, we aim to investigate whether NLR and PLR levels are associated with decline of kidney function in patients with CKD.
Detailed description
Chronic inflammation is closely associated with various chronic diseases, such as diabetes mellitus, cardiovascular disease, and chronic kidney disease (CKD) (1). Patients with CKD tend to have elevated levels of inflammatory mediators, including high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF alpha), and interleukin (IL)-6 (2).These mediators stimulate inflammatory pathway, leading to glomerular hypertension, tubulointerstitial fibrosis, kidney scarring, and, finally, CKD progression and increased cardiovascular events (3,4). Therefore, it is important to evaluate and decrease the extent of chronic inflammation in patients with CKD. Patients with CKD have higher levels of proinflammatory cytokines, but it remains unclear which biomarker is the best indicator of inflammation in patients with CKD.
The neutrophil-to-lymphocyte ratio (NLR), obtained by dividing the absolute number of neutrophils to the lymphocyte count, is increasingly studied as a new inflammatory marker. An elevated NLR has recently been reported to be an independent predictor of mortality in patients with cardiovascular disease or cancer [5-8]. As CKD is a chronic inflammatory disease, high NLR can predict CKD progression, cardiovascular disease and cancer. However, significantly few studies have investigated the association between high NLR and CKD progression [9-12].
Platelet-to-lymphocyte ratio (PLR) has recently been recognized as a novel inflammatory marker and has been shown to be associated with the prognosis in CKD patients [13].
In 2012, Kidney Disease: Improving Global Outcome (KDIGO) classified CKD in six categories by GFR estimation (in mL/min/1.73 m2).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Prevalence of Chronic Kidney disease (CKD) in 2017 was 7.1 million individuals globally and in Egypt was 106 patients per 1000 population estimated by (GBD) the Global Burden of Disease. In September 2021, about 10% of adult population is estimated to have CKD in the world, but the prevalence is higher in Egypt accounted for about 15-20% of adults.
Key inclusion criteria (1 listed)
- 200 Patients diagnosed with CKD and their age range between 18-65 years old who will be admitted at AUH.
Key exclusion criteria (8 listed)
- Pediatric patients aged below< 18 or elderly patients aged above 65.
- Pregnant females.
- Patients with Diabetes Mellitus.
- Acute kidney injury (AKI).
- Patients with current infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between NLR, PLR and severity of CKD.
Time frame: Baseline
Correlation between NLR, PLR and severity of CKD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Results publication: PubMed 35581444Gan W, Guan Q, Hu X, Zeng X, Shao D, Xu L, Xiao W, Mao H, Chen W. The association between platelet-lymphocyte ratio and the risk of all-cause mortality in chronic kidney disease: a systematic review and meta-analysis. Int Urol Nephrol. 2022 Nov;54(11):2959-2967. doi: 10.1007/s11255-022-03234-0. Epub 2022 May 17.
- Results publication: PubMed 30276600Altunoren O, Akkus G, Sezal DT, Ciftcioglu M, Guzel FB, Isiktas S, Torun GI, Uyan M, Sokmen MF, Sevim HA, Sarisik FN, Senel ME, Erken E, Gungor O. Does neutrophyl to lymphocyte ratio really predict chronic kidney disease progression? Int Urol Nephrol. 2019 Jan;51(1):129-137. doi: 10.1007/s11255-018-1994-7. Epub 2018 Oct 1.
- Results publication: PubMed 17167242Navarro JF, Milena FJ, Mora C, Leon C, Garcia J. Renal pro-inflammatory cytokine gene expression in diabetic nephropathy: effect of angiotensin-converting enzyme inhibition and pentoxifylline administration. Am J Nephrol. 2006;26(6):562-70. doi: 10.1159/000098004. Epub 2006 Dec 13.
- Results publication: PubMed 22172001Turkmen K, Guney I, Yerlikaya FH, Tonbul HZ. The relationship between neutrophil-to-lymphocyte ratio and inflammation in end-stage renal disease patients. Ren Fail. 2012;34(2):155-9. doi: 10.3109/0886022X.2011.641514. Epub 2011 Dec 16.
- Results publication: PubMed 22067929Manabe I. Chronic inflammation links cardiovascular, metabolic and renal diseases. Circ J. 2011;75(12):2739-48. doi: 10.1253/circj.cj-11-1184. Epub 2011 Nov 8.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD, run by Assiut University.
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 8 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: status not confirmed, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Said Ashamallah, Master (+201271131494 ext. +201064122166, Petersaid9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between NLR, PLR and severity of CKD. (time frame: Baseline). 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 NCT06670599, which also lists 5 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 1 Nov 2024.