| Trial ID: | L1301 |
| Source ID: | NCT02651428
|
| Associated Drug: |
Neutrolin
|
| Title: |
Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02651428/results
|
| Conditions: |
Kidney Failure, Chronic|Catheter-Related Infections
|
| Interventions: |
DRUG: Neutrolin|DRUG: Heparin
|
| Outcome Measures: |
Primary: Presence of a CAC-Adjudicated Catheter-Related Bloodstream Infection (CRBSI) in Subjects Receiving Hemodialysis for the Treatment of End Stage Renal Disease (ESRD): Final Analysis, CRBSI was defined as the same organism grown from at least one positive blood culture from a peripheral site or bloodline sample, or either the arterial or venous catheter hub. The final assessment of CRBSI was determined by a Clinical Adjudication Committee (CAC) who used both clinical documentation and blood culture results in their assessment., The event time was the number of days from randomization until the occurrence of a CAC-Adjudicated CRBSI or until the subject was censored. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). | Secondary: Participants With a Study Catheter Removal for Any Reason, Analysis of all catheter removals during the study or until the catheter was removed, The event time was the number of days from randomization until catheter removal for any reason or until the subject was censored. The mean participant duration of exposure to study drug was 174 days (range 4-884 days).
|
| Sponsor/Collaborators: |
Sponsor: CorMedix | Collaborators: PPD DEVELOPMENT, LP|JMI Laboratories|Spectra Clinical Research|Davita Clinical Research|Frenova Renal Research
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
806
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2015-12
|
| Completion Date: |
2018-10
|
| Results First Posted: |
2021-08-31
|
| Last Update Posted: |
2025-02-25
|
| Locations: |
Riverside Nephrology Physicians/Van Buren Dialysis center, Riverside, California, 92503, United States|North America Research Institute, San Dimas, California, 91773, United States|North Beach Dialysis Center Inc., Miami Gardens, Florida, 33169, United States|Lower Manhattan Dialysis Center, New York, New York, 10016, United States|Diagnostic Clinic of Houston, Houston, Texas, 77004, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02651428
|
