Clinical trials: Kidney Replacement Disorder
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 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 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
Kidney Failure, Chronic, Hemodialysis Complication
The Pristine Post-Market Study
This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter.
- Conditions
- Kidney Failure, Chronic, Hemodialysis Complication, Hemodialysis Catheter Infection, Hemodialysis Access Failure
- Trial name
- NCT05228132
- Testing
- Pristine™ Long-Term Hemodialysis Catheter
- Where
- 6 sites in United States
- Volunteers
- 142 people
- Sponsor
- C. R. Bard
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.
Arthroplasty, Replacement, Thromboembolism
Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment
- Trial name
- NCT00847301
- Where
- 53 sites in Austria, France and 5 more
- Volunteers
- 472 people
- Sponsor
- Boehringer Ingelheim
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 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
Acute Kidney Injury
A Study of Cell Therapy for Subjects With Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy
The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with Acute Kidney Injury (AKI) who require continuous renal replacement therapy.
- Trial name
- NCT03015623
- Testing
- SBI-101
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Sentien Biotechnologies, Inc.
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
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, Acute Kidney Injury Due to Sepsis
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
- Trial name
- SAVE (NCT06517810)
- Testing
- QUELIMMUNE (SCD-PED)
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- SeaStar Medical
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
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
Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis
- Trial name
- SBR759 (NCT00704483)
- Testing
- SBR759, Sevelamer HCl
- Where
- 66 sites in United States, Australia and 11 more
- Volunteers
- 321 people
- Sponsor
- Novartis Pharmaceuticals
Acute Kidney Injury
Nafamostat Efficacy in Phase 3 Registrational CRRT Study
A prospective, randomized, placebo-controlled clinical study to investigate the safety and efficacy of Niyad (nafamostat mesylate) for anticoagulation of extracorporeal blood circulating through a dialysis filter in patients…
- Trial name
- NEPHRO (NCT06150742)
- Testing
- Niyad (nafamostat mesylate)
- Where
- 10 sites in United States
- Volunteers
- 70 people
- Sponsor
- Talphera, Inc
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
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
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.
Chronic Kidney Diseases, Protein-Energy Malnutrition
Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Patients whit chronic kidney disease (CKD) there is a high prevalence of nutritional disorders and negative changes in body composition, which is strongly associated with an increased risk of morbidity and mortality.
- Trial name
- NCT06576479
- Testing
- Nutritious Shake, Nutritional counseling
- Where
- Mexico
- Volunteers
- 50 people
- Sponsor
- NIN Institute