A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
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|ClinicalTrials.gov Identifier: NCT02414841|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2015
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Drug: vonapanitase Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease|
|Actual Study Start Date :||August 2015|
|Estimated Primary Completion Date :||February 2019|
Active Comparator: Vonapanitase
Vonapanitase administered at the time of radiocephalic fistula creation
Other Name: PRT-201
Placebo Comparator: Placebo
Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition of vonapanitase but lacks the active ingredient.
- Co-primary endpoints of secondary patency and AVF use for hemodialysis [ Time Frame: 12 months ]Secondary patency is defined as the time from AVF creation until AVF abandonment. AVF use for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis has not been initiated at least 90 days prior to the patient's last visit.
- Unassisted AVF use for hemodialysis [ Time Frame: 12 months ]Unassisted AVF use for hemodialysis is defined as AVF use without prior procedures to restore or maintain patency.
- Primary unassisted patency [ Time Frame: 12 months ]Primary unassisted patency is defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain AVF patency.
- Maturation [ Time Frame: 3 months ]
Maturation by ultrasound criteria is defined by two definitions:
- As average cephalic vein luminal diameter ≥ 6 mm and outflow vein volume blood flow ≥ 600 mL/min by ultrasound.
- As average cephalic vein luminal diameter ≥ 4 mm and outflow vein volume blood flow ≥ 500 mL/min by ultrasound.
- Procedure rate [ Time Frame: 12 months ]The procedure rate is defined as the total number of procedure days divided by time on study per person year of follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414841
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