A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients - Full Text View

Sponsored by:	Proteon Therapeutics
Information provided by:	Proteon Therapeutics
ClinicalTrials.gov Identifier:	NCT00679991

Purpose

PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.

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

MedlinePlus related topics: Fistulas Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Further study details as provided by Proteon Therapeutics:

Primary Outcome Measures:

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. [ Time Frame: 2 & 6 weeks after AVF creation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis. [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PRT-201: Active Comparator	Drug: PRT-201 Applied topically to AVF during surgery
2: Placebo Comparator	Drug: Placebo Applied topically during AVF surgery

Eligibility

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

Criteria

Inclusion Criteria:

Age of at least 18 years.
Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
Planned creation of a new AVF.

Exclusion Criteria:

Patients for whom this is the only potential site for an AVF.
By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
Pregnancy, lactation or plans to become pregnant during the course of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679991

Contacts

Contact: Francesca Lindow

781 890-0102 ext 1028

fmlindow@proteontherapeutics.com

Locations

United States, Iowa
University of Iowa Hospitals and Clinics	Recruiting
Iowa City, Iowa, United States, 52242
Contact: Brad 319-353-6689
United States, Maine
Maine Medical Center	Not yet recruiting
Portland, Maine, United States, 04102
Contact 207-662-7191
United States, Massachusetts
Brigham and Women's Hospital	Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact 617-732-6816
Western New England Renal & Transplant Associates	Recruiting
Springfield, Massachusetts, United States, 01104
Contact 413-733-9666
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact 617-414-1011
United States, Missouri
Washington University in St. Louis	Recruiting
St. Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact 919-681-1093
United States, Ohio
University of Cincinnati Medical Center	Not yet recruiting
Cincinnati, Ohio, United States, 45267
Contact 513-281-0091 ext 117
United States, Texas
The Methodist Hospital	Not yet recruiting
Houston, Texas, United States, 77030
Contact 713-441-3672

Sponsors and Collaborators

Proteon Therapeutics

More Information

Responsible Party:	Proteon Therapeutics ( Steven Burke, M.D. )
Study ID Numbers:	PRT-201-101
Study First Received:	May 15, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00679991
Health Authority:	United States: Food and Drug Administration

Keywords provided by Proteon Therapeutics:

arteriovenous fistula
AVF
hemodialysis

vascular access
PRT 201
dose escalation

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Renal Insufficiency
Cardiovascular Abnormalities
Arteriovenous Fistula
Kidney Failure, Chronic
Vascular Diseases
Fistula

Urologic Diseases
Renal Insufficiency, Chronic
Vascular Malformations
Arteriovenous Malformations
Kidney Diseases
Congenital Abnormalities
Kidney Failure

Additional relevant MeSH terms:

Vascular Fistula
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009