A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)

Phase 3

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Placebo; Drug: PRT-201

• Registration Number: NCT02110901
• Lead Sponsor: Proteon Therapeutics

Brief Summary

This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Study Start: 2014-07
• Primary Completion: 2016-12
• Disposition First Submitted: 2017-06-06
• Disposition First Submitted QC: 2017-06-15
• Disposition First Posted: 2017-06-20
• Study Completion: 2018-12
• Results First Submitted: 2019-05-24
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-17
• Last Update Submitted: 2019-06-17
• Results First Posted: 2019-07-09
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

Inclusion Criteria

1. Age of at least 18 years.
2. Life expectancy of at least 6 months.
3. Diagnosis of Chronic Kidney Disease (CKD).
4. Planned creation of a new radiocephalic arteriovenous fistula (AVF)-revision of an existing AVF is not eligible.
5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team.
6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB).
7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra uterine device.

Exclusion Criteria

1. 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 or squamous cell skin cancer, or any cancer in situ.
2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
3. Previous treatment with PRT 201.
4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient.
PRT-201	PRT-201	PRT-201 administered at the time of radiocephalic fistula creation

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier Estimate of Secondary AVF Patency	Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year	Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency)
Time to AVF Primary Unassisted Patency	Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year	Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency.

Trial Locations

Locations (35)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

AKDHC Medical Research Services , LLC; 🇺🇸 Phoenix, Arizona, United States

AKDHC Medical Research Services, LLc; 🇺🇸 Tucson, Arizona, United States

Alliance Research Center; 🇺🇸 Laguna Hills, California, United States

VA Medical Center Long Beach; 🇺🇸 Long Beach, California, United States

Keck University Hospital at USC; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente Medical Center; 🇺🇸 San Diego, California, United States

California Institute of Renal Research; 🇺🇸 San Diego, California, United States

UCSF Division of Vascular & Endovascular Surgery; 🇺🇸 San Francisco, California, United States

Rush Medical Center; 🇺🇸 Chicago, Illinois, United States

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