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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Proteon Therapeutics
ClinicalTrials.gov Identifier:
NCT01305824
First received: February 16, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
 Drug: PRT-201
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Proteon Therapeutics:

Primary Outcome Measures:
  • Primary AVF patency. [ Time Frame: 12 months after AVF creation ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events as a measure of safety and tolerability of PRT-201. [ Time Frame: 12 months after AVF creation. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary Fistula Patency [ Time Frame: 12 months after AVF creation ] [ Designated as safety issue: Yes ]

Enrollment: 151
Study Start Date: March 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PRT 201 (10 micrograms) Drug: PRT-201
PRT-201 10 micrograms administered at the time of AVF creation.
Placebo Comparator: Placebo Drug: Placebo
Placebo administered at the time of AVF creation.
Active Comparator: PRT-201 (30 micrograms) Drug: PRT-201
PRT-201 30 micrograms administered at the time of AVF creation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305824

  Show 23 Study Locations
Sponsors and Collaborators
Proteon Therapeutics
  More Information

No publications provided

Responsible Party: Proteon Therapeutics
ClinicalTrials.gov Identifier: NCT01305824     History of Changes
Other Study ID Numbers: PRT-201-201
Study First Received: February 16, 2011
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Proteon Therapeutics:
arteriovenous fistula
AVF
hemodialysis
vascular access
 dialysis
fistula
PRT-201

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
 Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013