Chronic Kidney Failure Clinical Trial
Official title:
Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction
On line haemodiafiltration (OL-HDF) has been shown to improve intra-dialytic hemodynamics and cardiovascular outcomes. Several potential candidates of these beneficial effects have been explored. The aim of this study was to investigate the impact of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.
This is an open label placebo-controlled randomized clinical trial to assess the effect of
mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.
Inclusion criteria: age > 18 yrs, hemodialytic treatment from at least 6 months (3 times for
week), blood flow rate (Qb) ≥ 250 ml/min using arterovenous fistula (AVF) or permanent
central venous catheter (CVC), blood creatinine clearance <5 ml/min, urine output<500
ml/die.
Exclusion criteria: neoplastic diseases, chronic autoimmune diseases, lack of consent, solid
organ or bone marrow transplantation.
Safety Assessment: the use of mOL-HDF has been approved by the European Medicines Agency as
routine hemodepurative technique for end stage renal disease patients. Patients were
evaluated for adverse reaction at each dialysis section; investigators recorded intra and
extra-dialytic adverse events.
Study Treatment, Dosage, and Route of Administration: Enrolled patients have been randomized
in 2 groups: 15 patients continued high flux bicarbonate hemodialysis (BHD), whereas 15
patients switched to mixed on-line hemodiafiltration (mOL-HDF using FX 1000 CorDiax,
Fresenius Medical Care, Bad Homburg, Germany) for 9 months.
Efficacy Assessments:
Main outcome variable: changes in RNA content of circulating exosome/microvesicles (at 9
months) Secondary outcomes: changes in circulating inflammatory markers (C-Reactive Protein,
Neutrophil Gelatinase Associated Lipocalin, Interleukin-6, Ferritin) at 3-6 and 9 months.
changes in RNA content of circulating microvesicles (at 3 and 6 months)
Study Duration: 9 months
Statistical Methods: Data have been analyzed according to an intention-to-treat approach.
Statistical analysis was performed using the unpaired Student t -test, ANOVA, or
Kruskal-Wallis test when appropriate. A two-sided value of p=0.05 was considered
significant.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
| Completed |
NCT00781690 -
Reduction of Heparin Dose in Dialysis With Evodial System
|
N/A | |
| Completed |
NCT00806130 -
Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients
|
||
| Completed |
NCT00153621 -
Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric HIV-Infected Patients
|
N/A | |
| Completed |
NCT06165211 -
Nature-Based Sound Application For Hemodialysis Patients
|
N/A | |
| Not yet recruiting |
NCT04013620 -
CNI Transient Replacement by Belatacept From 3 to 12 Months Post Transplantation in Patients With Early Graft Dysfunction
|
Phase 3 | |
| Withdrawn |
NCT03998917 -
Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
|
||
| Completed |
NCT02586376 -
Effects of the Low-level Laser Therapy (LLLT) on Muscle Strength (MS) of the Patients With Kidneys Failure (KF)
|
N/A | |
| Completed |
NCT00794326 -
Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD
|
Phase 3 | |
| Completed |
NCT05185999 -
Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients
|
Phase 1 | |
| Completed |
NCT03076528 -
An Innovative Virtually Supervised Exercise for Dialysis Patients
|
Phase 2 | |
| Completed |
NCT02513303 -
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
|
Phase 3 | |
| Unknown status |
NCT00788905 -
Comparison of Conventional Dialysis and the Allient System
|
N/A | |
| Completed |
NCT00804453 -
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line
|
N/A | |
| Completed |
NCT01085552 -
Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects
|
Phase 1 | |
| Completed |
NCT00694824 -
Vascular Calcification's Risk Factors in Haemodialysis Patients
|
||
| Completed |
NCT00074620 -
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
|
Phase 2 | |
| Withdrawn |
NCT06030050 -
Animal Assisted Intervention for Hemodialysis Outpatients
|
N/A | |
| Recruiting |
NCT05562869 -
Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction
|
Phase 3 | |
| Completed |
NCT03437538 -
Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter
|
N/A |