Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial
Official title:
Molecular Mechanisms Involved in Cell Adhesion and Migration Process: Effect of Treatment of Chronic Kidney Disease on Endothelial Dysfunction
The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality.
The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality. Patients will be stratified by age, gender and the presence of diabetes. Routine analytical determinations (urea, creatinine, sodium, potassium, chlorine, total CO2, calcium, phosphorus, FA, PTH, levels 25OH, β2m, ALT, hemoglobin, leukocytes, platelets, glucose, uric acid, total proteins, albumin , PCR, IL-6, ferritin, TSAT and homocysteine), characteristics of hemodialysis and dialysis dose (Kt / V and Kt) will be recorded. Residual renal function will be analysed every three months. In plasma, microRNAs profile and FGF23 levels will be determined. Markers of endothelial dysfunction (CD31 +, CD41-, CD144, CD62E) and subclinical atherosclerosis markers (CD11b, CD41 +) will be measured. The hospitalization and mortality rate due to cardiovascular causes and concurrent cardiovascular events throughout the study (acute myocardial infarction, stroke, transient ischemic attack and peripheral vascular disease) will be assessed along the study period. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05700851 -
Immuno-nutrition Supplementation in Haemodialysis
|
N/A | |
Recruiting |
NCT02616627 -
Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
|
||
Completed |
NCT01464190 -
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
|
Phase 3 | |
Recruiting |
NCT06040281 -
Smart and Fit for Kidney Transplantation
|
N/A | |
Active, not recruiting |
NCT03535922 -
Evaluation of Routinely Measured Patient-reported Outcomes in Hemodialysis Care
|
N/A | |
Completed |
NCT04622709 -
Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis
|
Phase 2 | |
Completed |
NCT04585607 -
Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia
|
Phase 4 | |
Completed |
NCT03182699 -
Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients
|
Phase 4 | |
Completed |
NCT04549597 -
Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia
|
Phase 4 | |
Recruiting |
NCT04659525 -
Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia
|
Phase 4 | |
Completed |
NCT04125537 -
Pathways Project: Kidney Supportive Care
|
||
Recruiting |
NCT03347773 -
Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity
|
N/A | |
Recruiting |
NCT04397653 -
Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients
|
Phase 4 | |
Active, not recruiting |
NCT03938285 -
Effect of Hemodiafiltration Plus MCOs on Uremic Toxins Removal
|
N/A | |
Completed |
NCT03525223 -
Modulation of Tissue Sodium in Hemodialysis Patients
|
N/A | |
Completed |
NCT01324128 -
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
|
Phase 3 | |
Not yet recruiting |
NCT04600193 -
a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients
|
N/A | |
Not yet recruiting |
NCT06225544 -
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
|
Phase 2 | |
Recruiting |
NCT05209880 -
Advance Care Planning in the Emergency Department
|
N/A | |
Enrolling by invitation |
NCT05086185 -
Effect of Viscous Fiber on Postprandial Kalemic Response in Hemodialysis Patients
|