A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
This study has been completed.
Sponsor:
Proteon Therapeutics
Information provided by (Responsible Party):
Proteon Therapeutics
ClinicalTrials.gov Identifier:
NCT00679991
First received: May 15, 2008
Last updated: November 10, 2011
Last verified: November 2011
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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 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
capillary malformation-arteriovenous malformation syndrome
Parkes Weber syndrome
U.S. FDA Resources
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: Yes ]
| Enrollment: | 66 |
| Study Start Date: | November 2008 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: PRT-201 |
Drug: PRT-201
Applied topically to AVF during surgery
Drug: PRT-201
Dose escalation study. Drug/placebo administered at the time of fistula creation
|
| Placebo Comparator: 2 |
Drug: PRT-201
Dose escalation study. Drug/placebo administered at the time of fistula creation
|
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
Locations
| United States, Indiana | |
| Clarian Health Partners/Indiana University/Purdue University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Western New England Renal & Transplant Associates | |
| Springfield, Massachusetts, United States, 01104 | |
| United States, Missouri | |
| Washington University in St. Louis | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Sentara Medical Group | |
| Norfolk, Virginia, United States, 23507 | |
Sponsors and Collaborators
Proteon Therapeutics
More Information
No publications provided
| Responsible Party: | Proteon Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00679991 History of Changes |
| Other Study ID Numbers: | PRT-201-101 |
| Study First Received: | May 15, 2008 |
| Last Updated: | November 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Proteon Therapeutics:
|
arteriovenous fistula AVF hemodialysis vascular access PRT 201 |
dose escalation dialysis fistula access |
Additional relevant MeSH terms:
|
Arteriovenous Fistula Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Arteriovenous Malformations Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases |
Vascular Fistula Vascular Diseases Congenital Abnormalities Fistula Pathological Conditions, Anatomical Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 22, 2013