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Clinical Trial Details

Trial ID: L0262
Source ID: NCT00679991
Associated Drug: Prt-201
Title: A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: PRT-201|DRUG: PRT-201
Outcome Measures: Primary: To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein., 2 & 6 weeks after AVF creation | Secondary: The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis., 3, 6, 9, and 12 months
Sponsor/Collaborators: Sponsor: Proteon Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 66
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-11
Completion Date: 2011-07
Results First Posted:
Last Update Posted: 2015-04-30
Locations: Clarian Health Partners/Indiana University/Purdue University, Indianapolis, Indiana, 46202, United States|University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States|Maine Medical Center, Portland, Maine, 04102, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States|Western New England Renal & Transplant Associates, Springfield, Massachusetts, 01104, United States|Washington University in St. Louis, St. Louis, Missouri, 63110, United States|Weill Cornell Medical College, New York, New York, 10065, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|University of Cincinnati Medical Center, Cincinnati, Ohio, 45267, United States|The Methodist Hospital, Houston, Texas, 77030, United States|Sentara Medical Group, Norfolk, Virginia, 23507, United States
URL: https://clinicaltrials.gov/show/NCT00679991

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress