Clinical trial NCT06670599: Neutrophil-to-Lymphocyte and Platelet-to-lymphocyte Ratios as a Predictor Factors for Chronic Kidney Disease Progression
Official title: Neutrophil-to-Lymphocyte and Platelet-to-lymphocyte Ratios as a Predictor Factors for Chronic Kidney Disease Progression
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CKD
Keywords: NLR &amp; PLR in CKD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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).

Eligibility criteria: Inclusion Criteria:

* 200 Patients diagnosed with CKD and their age range between 18-65 years old who will be admitted at AUH.

Exclusion Criteria:

1. Pediatric patients aged below\< 18 or elderly patients aged above 65.
2. Pregnant females.
3. Patients with Diabetes Mellitus.
4. Acute kidney injury (AKI).
5. Patients with current infections.
6. Patients who have any type of malignancy.
7. Patients who have any type of multi-organ failure.
8. CKD patients on dialysis

Primary outcomes:
measure: Correlation between NLR, PLR and severity of CKD.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Altunoren 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.
citation: Navarro 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.
citation: Turkmen 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.
citation: Manabe 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.