Clinical trials: Renal Replacement Therapies
Chronic Renal Anemia
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not…
- Trial name
- NCT00773513
- Testing
- Darbepoetin Alfa, Epoetin Alfa, Epoetin Beta
- Where
- 196 sites in Argentina, Australia and 25 more
- Volunteers
- 2,825 people
- Sponsor
- Hoffmann-La Roche
Renal Failure, End Stage Renal Disease
Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane
The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone…
- Trial name
- eMPORA (NCT03315624)
- Testing
- Dialyzer
- Where
- Germany
- Volunteers
- 49 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Arthroplasty, Replacement, Prevention of Venous Thromboembolism
Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate
To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip…
- Conditions
- Arthroplasty, Replacement, Prevention of Venous Thromboembolism, Moderate Renal Impairment (CrCl 30-50 mL/Min)
- Trial name
- NCT01184989
- Testing
- Dabigatran etexilate
- Where
- 10 sites in Austria, Canada and 4 more
- Volunteers
- 142 people
- Sponsor
- Boehringer Ingelheim
AKI - Acute Kidney Injury, Acute Renal Failure
A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter
The goal of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter in patients with acute kidney injury, acute renal failure, or chronic kidney disease.
- Conditions
- AKI - Acute Kidney Injury, Acute Renal Failure, CKD, ESRD
- Trial name
- NCT05888376
- Testing
- Vascular access catheter to support dialysis or CRRT
- Where
- 2 sites in Poland
- Volunteers
- 76 people
- Sponsor
- Vantive Health LLC
Renal Insufficiency / Therapy
PD Catheter Data Collection
Peritoneal Dialysis (PD) is a Renal Replacement Therapy for patients with renal insufficiency that has been used more frequently in recent years.
- Trial name
- Catheter (NCT07156123)
- Where
- 2 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Renal Failure, End Stage Renal Disease
Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers
The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both…
- Trial name
- NCT04749680
- Testing
- PD cycler Silencia
- Where
- 4 sites in Chile
- Volunteers
- 16 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT)
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit.
- Conditions
- Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury (AKI)
- Trial name
- NCT05399537
- Testing
- Prismocitrate 18, PrisMax System Version 3.x with calcium line accessory
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Vantive Health LLC
Anemia
A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis.
- Trial name
- NCT00048048
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 15 sites in United States, Canada and 3 more
- Volunteers
- 65 people
- Sponsor
- Hoffmann-La Roche
Acute Kidney Injury, Renal Failure
Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation
The goal of this observational study is to assess the performance of the multiFlux hemofilterwith regional or systemic anticoagulation during CKRT treatments.
- Trial name
- RCA-Flux (NCT07679568)
- Testing
- multiFlux 160 hemofilter with regional heparin anticoagulation, multiFlux 160 hemofilter with RCA with regional citrate anticoagulation, multiFlux 130 hemofilter with regional heparin anticoagulation
- Where
- Germany
- Volunteers
- 62 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Anemia
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.
- Trial name
- NCT00255424
- Testing
- ferumoxytol or oral iron
- Where
- 19 sites in United States
- Volunteers
- 304 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Continuous Renal Replacement Therapy, Pulmonary Edema
C2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19
The clinical trial will evaluate the short term and extended impact on on respiration, pulmonary function and cardiovascular function in C2Rx treatment verse Standard of Care (SOC) in critically ill adults with COVID-19…
- Conditions
- Continuous Renal Replacement Therapy, Pulmonary Edema, COVID-19
- Trial name
- NCT04537975
- Testing
- C2Rx, Standard of Care (SOC)
- Sponsor
- SeaStar Medical
Acute Kidney Injury
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI).
- Trial name
- SCD-PED-01 (NCT02820350)
- Testing
- SCD-F40
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- CytoPherx, Inc
COVID-19
Registry of CytoSorb Therapy in COVID-19 ICU Patients
The CTC Registry collects patient-level clinical data on CytoSorb hemoadsorption provided to COVID-19 ICU patients via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.
- Trial name
- CTC REGISTRY (NCT04391920)
- Testing
- CytoSorb 300 mL device
- Where
- 7 sites in United States
- Volunteers
- 138 people
- Sponsor
- CytoSorbents, Inc
Renal Failure, Cardiovascular Diseases
HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life Assessed by MRI Scanning
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques.
- Conditions
- Renal Failure, Cardiovascular Diseases, Congenital Disorders
- Trial name
- HD-REMODEL (NCT03280901)
- Testing
- HD, Magnetic Resonance Imaging (MRI) scans
- Where
- United Kingdom
- Volunteers
- 17 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Renal Failure, Chronic Kidney Disease
Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony
- Trial name
- FlexPoint (NCT06390592)
- Testing
- PD cycler
- Volunteers
- 24 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Acute Kidney Injury, ESRD
SAfety of Regional Citrate Anticoagulation (SARCA Study)
This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA…
- Trial name
- SARCA (NCT05339139)
- Testing
- Dialysis
- Where
- 10 sites in United States
- Volunteers
- 32 people
- Sponsor
- Fresenius Medical Care North America
ESRD, Hemodialysis
The Evaluation of the DIMI RRT System In-Center to Demonstrate Safety and Usability in the Home Environment
This is a prospective, multicenter, open label, non-randomized, cross-over study. Subjects will be enrolled in the trial for approximately 18 weeks and will use the DIMI RRT System for their dialysis treatments for all study…
- Trial name
- NCT04868643
- Testing
- The DIMI Renal Replacement Therapy (RRT) System
- Sponsor
- Dialco Medical Inc.
Acute Kidney Injury
Safety and Performance Evaluation of multiPlus Dialysate During CRRT
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6 hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration [CVVHD(F)].
- Trial name
- multiPlus (NCT05315817)
- Testing
- multiPlus dialysate
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
Acute Lung Injury, Acute Kidney Injury
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy
Objective of the study is to assess the safety and efficacy of CO2 removal by the multiECCO2R (CO2 Removal System) on the multiFiltrate/multiFiltrate Pro in veno-venous extracorporeal circulation during continuous renal…
- Conditions
- Acute Lung Injury, Acute Kidney Injury, Hypercapnia, Covid19
- Trial name
- multiECCO2R (NCT04871893)
- Testing
- multiECCO2R blood-gas exchanger
- Where
- 6 sites in Germany
- Volunteers
- 28 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH