Clinical Trial Details
| Trial ID: | L0239 |
| Source ID: | NCT02110901 |
| Associated Drug: | Prt-201 |
| Title: | A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02110901/results |
| Conditions: | Chronic Kidney Disease |
| Interventions: | DRUG: PRT-201|DRUG: Placebo |
| Outcome Measures: | Primary: Time to AVF Primary Unassisted Patency, Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency., Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year|Kaplan-Meier Estimate of Secondary AVF Patency, Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency), Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year | Other: Number of Participants With Unassisted AVF Maturation by Ultrasound, AVF maturation is defined as average cephalic vein lumen diameter \>= 4 mm and an outflow vein volume blood flow \>= 500 mL/min by ultrasound without prior primary unassisted patency loss., Assessed 3 months after AVF creation|Number of Participants With Unassisted AVF Use for Hemodialysis, Unassisted AVF use for hemodialysis is defined as continuous use of the AVF for hemodialysis without prior primary unassisted patency loss. Use of the AVF for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis was not initiated at least 90 days prior to the last visit. Non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF by the rules described above have insufficient data to determine use for hemodialysis and will be categorized as having indeterminate use., Assessed at 12 months |
| Sponsor/Collaborators: | Sponsor: Proteon Therapeutics |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 349 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2014-07 |
| Completion Date: | 2018-12 |
| Results First Posted: | 2019-07-09 |
| Last Update Posted: | 2019-07-09 |
| Locations: | University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|AKDHC Medical Research Services , LLC, Phoenix, Arizona, 85012, United States|AKDHC Medical Research Services, LLc, Tucson, Arizona, 85719, United States|Alliance Research Center, Laguna Hills, California, 92653, United States|VA Medical Center Long Beach, Long Beach, California, 90822, United States|Keck University Hospital at USC, Los Angeles, California, 90033, United States|Kaiser Permanente Medical Center, San Diego, California, 92120, United States|California Institute of Renal Research, San Diego, California, 92123, United States|UCSF Division of Vascular & Endovascular Surgery, San Francisco, California, 94143, United States|Rush Medical Center, Chicago, Illinois, 60612, United States|Renal Care Associates, Peoria, Illinois, 61603, United States|Lutheran Hospital Network of Indiana, Fort Wayne, Indiana, 46804, United States|University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States|University of Louisville, Louisville, Kentucky, 40202, United States|Tulane University, New Orleans, Louisiana, 70112, United States|Louisiana State University Health Sciences Center, Shreveport, Louisiana, 71130, United States|Maine Medical Center, Portland, Maine, 04102, United States|University of Maryland, Baltimore, Maryland, 21201, United States|University of Maryland Shore Medical Center at Easton, Easton, Maryland, 21601, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02482, United States|University of Massachusetts Medical Center, Worcester, Massachusetts, 01655, United States|Mount Sinai Medical Center, New York, New York, 10029, United States|University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States|Duke University, Durham, North Carolina, 27710, United States|W.G. Hefner VA Medical Center, Salisbury, North Carolina, 28144, United States|Wake Forest, Winston-Salem, North Carolina, 27157, United States|University of Cincinnati Medical Center, Cincinnati, Ohio, 45267, United States|University of Cincinnati, Cincinnati, Ohio, 45267, United States|Ohio State University, Columbus, Ohio, 43210, United States|The University of Oklahoma College of Medicine, Tulsa, Oklahoma, 74104, United States|Lehigh Valley Health Network, Allentown, Pennsylvania, 18103, United States|VA Pittsburg Healthcare System, Pittsburgh, Pennsylvania, 15240, United States|The Methodist Hospital, Houston, Texas, 77030, United States|Lake Washington Vascular Center, Bellevue, Washington, 98004, United States |
| URL: | https://clinicaltrials.gov/show/NCT02110901 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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