Clinical trials: Kidney Replacement
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
Prevention of Thromboembolic Events
Study to Assess the Safety, Tolerability, Effects on the Body, Absorption, Distribution and Elimination of 25 mg BAY2433334 in Renal Impairment Including Renal Replacement Therapy ("Dialysis")
BAY2433334 is under clinical development for prevention of complications in diseases such as heart attack, irregular heart beat or stroke which can arise by formation of blood clots elsewhere in the body and travels through the…
- Trial name
- NCT04510987
- Testing
- BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5, BAY2433334 on dialysis treatment day
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- Bayer
Psychological Stress, Cardiopulmonary Bypass Surgery
CARINAE for Stress Relief in Perioperative Care
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure.
- Conditions
- Psychological Stress, Cardiopulmonary Bypass Surgery, Coronary Artery Bypass Surgery, Cardiac Valve Replacement
- Trial name
- CARINAE (NCT05184725)
- Testing
- SaMD CARINAE
- Where
- 5 sites in Italy, Netherlands and 1 more
- Volunteers
- 50 people
- Sponsor
- Adhera Health, 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
Systemic Inflammatory Response Syndrome, Acute Kidney Injury
High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI).
- Trial name
- HICOSIRS (NCT01579396)
- Testing
- septeX, standard therapy
- Where
- Germany
- Sponsor
- Vantive Health LLC
Acute Renal Failure
Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure
The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute renal failure (ARF).
- Trial name
- NCT01072682
- Testing
- Selective cytopheretic device (SCD)
- Where
- 7 sites in United States
- Volunteers
- 35 people
- Sponsor
- SeaStar Medical
Liver Cirrhosis
Alfapump-albumin Replacement Therapy
The study will be a single centre, open-label trial. The patients will have a diagnosis of refractory ascites and will meet specified inclusion/exclusion criteria Informed consent will be obtained from all patients.
- Trial name
- NCT02448160
- Testing
- alfapump, salt-poor Human Albumin solution
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Sequana Medical N.V.
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
End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis
Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but…
- Conditions
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure, Peritoneal Dialysis
- Trial name
- NCT04292210
- Testing
- Perisafe
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Peripal AG
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
Renal Failure, End Stage Renal Disease
Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
- Conditions
- Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
- Trial name
- NCT02644941
- Testing
- Human Acellular Vessel (HAV), ePTFE graft
- Where
- 38 sites in United States, Germany and 4 more
- Volunteers
- 355 people
- Sponsor
- Humacyte, Inc.
Septic Shock
Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane
This study aims to demonstrate equivalence in terms of molecule removal between continuous hemodialysis using an "enhanced middle molecule clearance" membrane(Ultraflux EMiC2) and continuous hemofiltration using a standard…
- Trial name
- NCT01067313
- Testing
- Dialyzer Ultraflux EMiC2, Dialyzer Ultraflux AV1000S
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Fresenius Medical Care France
Renal Failure, End Stage Renal Disease
Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration
The clinical investigation will be performed to generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil…
- Trial name
- comPERFORMStud (NCT04102280)
- Testing
- Dialyser
- Where
- 4 sites in Germany
- Volunteers
- 52 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Acute Kidney Injury, Renal Failure
Retrospective Data Analysis of CKRT (Continuous Kidney Replacement Therapy) Treatments in Adult Mode With multiFiltratePRO
The multiFiltratePRO is a device for extracorporeal blood purification treatments. In this retrospective analysis, the treatments of patients who received at least one treatment with the investigational device as mentioned…
- Trial name
- CKRT-AKI (NCT06236984)
- Testing
- multiFiltratePRO with all CKRT treatment modes
- Where
- 3 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Anemia, Renal Failure, Chronic Renal Failure
Effects of Early Correction of Anemia in Patients With Chronic Renal Insufficiency
The purpose of the study is to assess the effect of an early and complete correction of anemia after treatment with epoetin alfa on the rate of progression of chronic renal failure (which involves improper functioning of the…
- Trial name
- NCT00312871
- Testing
- Epoetin alfa
- Volunteers
- 217 people
- Sponsor
- Janssen Cilag S.A.S.
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
COVID-19, Acute Kidney Injury
A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy
The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI).
- Conditions
- COVID-19, Acute Kidney Injury, Sepsis
- Trial name
- NCT04445220
- Testing
- SBI-101
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Sentien Biotechnologies, Inc.
Renal Failure, End Stage Renal Disease
Comparison of Clinical Performance and Hemocompatibility of Dialyzers Applied During Post-dilution Online Hemodiafiltration
Comparison of the clinical performance and the hemocompatibility profile of different high-flux dialyzers, all applied during post-dilution online hemodiafiltration
- Trial name
- eMPORAIII (NCT04714281)
- Testing
- Dialyser
- Where
- 8 sites in Czechia, Germany and 1 more
- Volunteers
- 82 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Acute Kidney Injury in Pediatric Patients
Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children
The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex® HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement therapy to effectively treat acute kidney injury…
- Trial name
- NCT02561247
- Testing
- Prismaflex HF20 CRRT Filter, Prismaflex® System 7.10 and 7.20
- Where
- 6 sites in United States
- Volunteers
- 23 people
- Sponsor
- Vantive Health LLC
Renal Replacement Therapy
Blood Viscosity, End-Stage Renal Disease, And Mortality (BEAM-1)
Prospective, real-time observational study of hemodialysis patients treated with erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets.
- Trial name
- BEAM-1 (NCT01023893)
- Volunteers
- 400 people
- Sponsor
- ProMetrics, Inc.