Chronic Kidney Disease Clinical Trial
Official title:
Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Verified date | April 2015 |
Source | Proteon Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.
Status | Completed |
Enrollment | 151 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age of at least 18 years. 2. Life expectancy of at least 6 months. 3. Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months. 4. Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable. Exclusion Criteria: 1. History or presence of an arterial aneurysm. 2. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell cancer, squamous cell skin cancer, or any cancer in situ. 3. Hepatic dysfunction defined as bilirubin, ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices. 4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Vascular Specialty Center | Baton Rouge | Louisiana |
United States | Beth Israel Deconness Hospital | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Rush Medical Center | Chicago | Illinois |
United States | St Clair Specialty Physicians | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Indiana Ohio Heart | Fort Wayne | Indiana |
United States | The Methodist Hospital | Houston | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | University of Iowa | Iowa City | Iowa |
United States | Thoracic & Cardiovascular Healthcare Foundation | Lansing | Michigan |
United States | University of Louisville | Louisville | Kentucky |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Weill Cornell Medical College | New York | New York |
United States | Sentara Medical Group | Norfolk | Virginia |
United States | Renal Care Associates | Peoria | Illinois |
United States | Legacy Oregon Surgical | Portland | Oregon |
United States | California Institute of Renal Research | San Diego | California |
United States | Kaiser Permanente | San Diego | California |
United States | UCSF | San Francisco | California |
United States | UMASS Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Proteon Therapeutics |
United States,
Hye RJ, Peden EK, O'Connor TP, Browne BJ, Dixon BS, Schanzer AS, Jensik SC, Dember LM, Jaff MR, Burke SK. Human type I pancreatic elastase treatment of arteriovenous fistulas in patients with chronic kidney disease. J Vasc Surg. 2014 Aug;60(2):454-461.e1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary AVF patency. | 12 months after AVF creation | Yes | |
Primary | Number of participants with adverse events as a measure of safety and tolerability of PRT-201. | 12 months after AVF creation. | Yes | |
Secondary | Secondary Fistula Patency | 12 months after AVF creation | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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