A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— PRT-201-102  

Official title:

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Graft Creation in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001351
• Other study ID #: PRT-201-102
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 22, 2009
• Last updated: April 8, 2015
• Start date: September 2009
• Est. completion date: November 2012

Study information

• 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

Clinical Trial Summary

PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis. Recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. This clinical trial will explore the safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly placed upper extremity AVG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• 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. Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.

3. Planned creation of a new upper extremity AVG or "jump" graft

Exclusion Criteria:

1. Patients for whom this is the only potential site for an upper extremity vascular access.

2. Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent.

3. On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion.

4. History or presence of an arterial aneurysm.

5. Previous treatment with PRT-201.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• PRT-201
Applied topically during surgery.
• Placebo
Applied topically during surgery

Locations

Country	Name	City	State
United States	Vascular Specialty Center	Baton Rouge	Louisiana
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	University of Cincinnati	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Indiana/Ohio Heart	Fort Wayne	Indiana
United States	Ladenheim Dialysis Access Center	Fresno	California
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	The Methodist Hospital	Houston	Texas
United States	Indiana University/Purdue University	Indianapolis	Indiana
United States	University of Louisville	Louisville	Kentucky
United States	Weill Cornell Medical College	New York	New York
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	Peripheral Vascular Associates	San Antonio	Texas
United States	California Institute of Renal Research	San Diego	California
United States	Washington Hospital/Medstar Research	Washington	District of Columbia
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Proteon Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dwivedi AJ, Roy-Chaudhury P, Peden EK, Browne BJ, Ladenheim ED, Scavo VA, Gustafson PN, Wong MD, Magill M, Lindow F, Blair AT, Jaff MR, Franano FN, Burke SK. Application of human type I pancreatic elastase (PRT-201) to the venous anastomosis of arterioven — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety of a single topical dose of PRT-201.		Day of AVG creation and 4 weeks After surgery.	Yes
Secondary	Primary graft patency		3, 6, 9 and 12 months after AVG creation.	Yes
Secondary	Secondary graft patency.		3, 6, 9 and 12 months after AVG creation.	Yes