Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02651428

Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection

Kidney Failure, Chronic Clinical Trial

Official title:
Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of Neutrolin in Preventing Catheter-related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease

Clinical Trial Summary

The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.

Clinical Trial Description

The objective of this study is to demonstrate the efficacy and safety of Neutrolin® as a catheter lock solution (CLS) on prevention of catheter-related bloodstream infection (CRBSI), and the incidence of treatment-emergent adverse events in subjects receiving hemodialysis (HD) for the treatment of End Stage Renal Disease (ESRD) when compared with heparin 4,000 USP Units/4mL (1,000 USP Units/mL). This is a randomized, double-blind, active control, parallel-arm, multicenter study. Six hundred and thirty two subjects will be randomized in a 1:1 ratio to receive either Neutrolin® or the active control heparin (Heparin sodium USP 1,000 units/mL, Benzyl alcohol 9.45 mg/mL and Sodium chloride 9.0 mg/mL) as a CLS. Approximately 632 randomized subjects are planned for this trial. In this study, one-half of the subjects (316 subjects) will receive Neutrolin as a study drug and the other half will receive heparin 4,000 USP Units/4mL (1,000 USP Units/mL) with benzyl alcohol preservative as a comparator. Subjects will be assigned in a 1:1 ratio using permuted blocks without additional stratification for both groups. The primary objective of this study is to demonstrate the effectiveness of Neutrolin® as a CLS in ESRD subjects undergoing HD treatment using a permanent, cuffed, tunneled silicone or polyurethane HD catheter. The study will evaluate whether Neutrolin® is superior to the active control heparin by documenting the time to CRBSI and consequently delaying the time until the occurrence of CRBSI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02651428
Study type Interventional
Source CorMedix
Contact
Status Completed
Phase Phase 3
Start date December 2015
Completion date October 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT03246984 - VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ N/A
Completed NCT02922361 - Spending and Outcomes for Complex Medicare Advantage Patients
Completed NCT02235571 - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Completed NCT01930396 - Use of Tinzaparin for Anticoagulation in Hemodialysis Phase 4
Completed NCT01922843 - A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis Phase 2
Not yet recruiting NCT01674660 - Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients N/A
Not yet recruiting NCT01157260 - The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease Phase 4
Completed NCT01209403 - Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients Phase 4
Completed NCT00753116 - Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension Phase 1
Recruiting NCT00532688 - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure Phase 2/Phase 3
Completed NCT00534144 - Comparison Between Effects of Two Iron Preparations on Protein in the Urine Phase 1
Completed NCT00528788 - How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis Phase 4
Completed NCT00226902 - Vascular Reactivity in Kidney Disease Patients N/A
Completed NCT00382044 - Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients N/A
Recruiting NCT00235287 - Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease Phase 4
Completed NCT00224081 - DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) Phase 4
Completed NCT00071214 - Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis Phase 3
Completed NCT00049907 - Cardiac and Renal Disease Study (CARDS) N/A
Completed NCT00006297 - Risk Factors for CV Disease in a Dialysis Cohort N/A