End Stage Renal Disease on Dialysis Clinical Trial
Official title:
The Immune System in End Stage Chronic Kidney Disease (CKD) Patients - Comparison Among Different Modalities of Renal Replacement Therapy (RRT)
The evaluation and assessment of the influence of the different modalities of renal replacement therapy (RRT), including peritoneal dialysis (PD), conventional hemodialysis with high flux dialyzers, hemodiafiltration (HDF) and expanded hemodialysis (HDx) with Medium Cut Off (MCO) dialyzers on the levels of the cell subsets of the innate and acquired immune system as well as the investigation of the possible role of these cells as prognostic indices of morbidity and mortality in patients with end-stage Chronic Kidney Disease (CKD) undergoing different modalities of RRT.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | December 31, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - adult patients between 18 and <90 years - CKD G5 (glomerular filtration rate (GFR) <15 ml/min/1.73m2) - conventional hemodialysis treatment thrice weekly for at least three months via permanent vascular access - patients undergoing PD for at least three months. Exclusion Criteria: - presence of infection - active malignancy - liver cirrhosis - inflammatory bowel disease - active autoimmune disease - decompensated heart failure (New York Heart Association (NYHA) IV - occurence of a major cardiovascular event within less that three months |
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Ioannina | Ioánnina |
Lead Sponsor | Collaborator |
---|---|
University of Ioannina | Baxter Healthcare Corporation |
Greece,
Caprara C, Kinsey GR, Corradi V, Xin W, Ma JZ, Scalzotto E, Martino FK, Okusa MD, Nalesso F, Ferrari F, Rosner M, Ronco C. The Influence of Hemodialysis on T Regulatory Cells: A Meta-Analysis and Systematic Review. Blood Purif. 2016;42(4):307-313. Epub 2016 Oct 1. — View Citation
Heine GH, Ulrich C, Seibert E, Seiler S, Marell J, Reichart B, Krause M, Schlitt A, Köhler H, Girndt M. CD14(++)CD16+ monocytes but not total monocyte numbers predict cardiovascular events in dialysis patients. Kidney Int. 2008 Mar;73(5):622-9. Epub 2007 Dec 26. — View Citation
Kim HW, Yang HN, Kim MG, Choi HM, Jo SK, Cho WY, Kim HK. Microinflammation in hemodialysis patients is associated with increased CD14CD16(+) pro-inflammatory monocytes: possible modification by on-line hemodiafiltration. Blood Purif. 2011;31(4):281-8. doi: 10.1159/000321889. Epub 2011 Jan 14. — View Citation
Vacher-Coponat H, Brunet C, Lyonnet L, Bonnet E, Loundou A, Sampol J, Moal V, Dussol B, Brunet P, Berland Y, Dignat-George F, Paul P. Natural killer cell alterations correlate with loss of renal function and dialysis duration in uraemic patients. Nephrol Dial Transplant. 2008 Apr;23(4):1406-14. Epub 2007 Nov 20. — View Citation
Wolley M, Jardine M, Hutchison CA. Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules. Clin J Am Soc Nephrol. 2018 May 7;13(5):805-814. doi: 10.2215/CJN.10110917. Epub 2018 Mar 5. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the peripheral blood levels of the cell subsets of the innate and acquired immune system in patients with end-stage CKD transitioning from hemodialysis to hemodiafiltration or expanded hemodialysis. | Immune cell subtypes (CD14++CD16- monocytes, CD14++CD16+ monocytes, CD 14+CD16+ monocytes, NK cells, CD4+ lymphocytes, CD8+ lymphocytes and Tregs) will be measured by flow cytometry at baseline in patients undergoing hemodialysis in the midweek dialysis session. 15 of patients undergoing conventional hemodialysis will be allocated to online-HDF with the same dialyzer and 15 conventional hemodialysis patients will be allocated to HDx with an MCO dialyzer (THERANOVA dialyzer, Baxter International Inc. (NYSE: BAX)), for 12 weeks. Immune cell subtypes will be measured in the 12th week. | 1st-12th week | |
Primary | Comparison of the peripheral blood levels of the cell subsets of the innate and acquired immune system in patients with end-stage CKD undergoing hemodiafiltration versus expanded hemodialysis. | Patients allocated to online-HDF and patients allocated to HDx with an MCO dialyzer (THERANOVA dialyzer, Baxter International Inc. (NYSE: BAX)), will be allocated to conventional hemodialysis for 4 weeks as a wash-out phase and then they will be crossed over to online-HDF and HDx with THERANOVA dialyzer for 12 weeks. Immune cell subtypes (CD14++CD16- monocytes, CD14++CD16+ monocytes, CD 14+CD16+ monocytes, NK cells, CD4+ lymphocytes, CD8+ lymphocytes and Tregs)will be measured by flow cytometry in the 28th week. | 12th-28th | |
Primary | Comparison between the peripheral blood levels of the cell subsets of the innate and acquired immune system in patients with end-stage CKD undergoing hemodialysis, hemodiafiltration, expanded hemodialysis and peritoneal dialysis. | Immune cell subtypes (CD14++CD16- monocytes, CD14++CD16+ monocytes, CD 14+CD16+ monocytes, NK cells, CD4+ lymphocytes, CD8+ lymphocytes and Tregs)will be measured in 15 PD patients during a programmed visit at the PD unit. | 12-28th | |
Secondary | Correlation between peripheral blood levels of the cell subsets of the innate and acquired immune system with dialysis adequacy, adequacy of fluid control, nutritional indices, and inflammatory markers. | Correlations will be made between peripheral blood levels of CD14++CD16- monocytes, CD14++CD16+ monocytes, CD 14+CD16+ monocytes, NK cells, CD4+ lymphocytes, CD8+ lymphocytes and Tregs (at all time points measured as described in primary otcome) as assessed with flow cytometry with dialysis adequacy (KT/V, URR, residual renal function), adequacy of fluid control (dry body weight, body composition monitoring (BCM), lung ultrasound), nutritional indices (serum albumin, normalized protein catabolic rate (nPCR) and inflammatory markers (CRP, serum ferritin, IL-6, tumor necrosis factor a (TNFa, growth and differentiation factor 15 (GDF15), galectin3, interleukin 1 receptor-like 1 also known as ST2 etc.). | 1st - 48th week | |
Secondary | Correlation between peripheral blood levels of the cell subsets of the innate and acquired immune system with established cardiovascular disease, atherosclerosis markers, indicesof systolic and diastolic cardiac function and occurrence of infections. | A correlation will be sought between peripheral blood levels of CD14++CD16- monocytes, CD14++CD16+ monocytes, CD 14+CD16+ monocytes, NK cells, CD4+ lymphocytes, CD8+ lymphocytes with presence of established cardiovascular disease (heart failure, ischemic heart disease), markers of atherosclerosis (IMT), with indices of systolic and diastolic cardiac function (left ventricular ejection fraction (LVEF), E and A wave, mitral annular plane systolic excursion (MAPSE) septal and lateral, deceleration time, left atrium dimensions, pulmonary artery systolic pressure, inferior vena cava diameter) and finally with occurrence of infections. | 1st - 48th week | |
Secondary | Prognostic indices of morbidity (hospitalizations, cardiovascular events, infections) and mortality (due to any cause or cardiovascular mortality). | The prospective part of the study will be the investigation of the possible role of the evaluated cell subsets of the innate and acquired immune system (monocyte subsets, NK cells, CD4 and CD8 lymphocytes and T regs) as prognostic indices of morbidity (hospitalizations, cardiovascular events, infections) and mortality (due to any cause or cardiovascular mortality). | 24 months |
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