A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Proteon Therapeutics

Status and phase

Completed

Phase 2

Conditions

Chronic Kidney Disease

Treatments

Drug: Placebo

Drug: PRT-201

Study type

Interventional

Funder types

Industry

Identifiers

NCT01305824

PRT-201-201

Details and patient eligibility

About

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.

Enrollment

151 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age of at least 18 years.
Life expectancy of at least 6 months.
Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.

Exclusion criteria

History or presence of an arterial aneurysm.
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.
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.
Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.