Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-31 @ 8:49 PM
Study NCT ID:
NCT01001351
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2009-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C017130', 'term': 'cholesterol-binding protein'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'dispFirstSubmitDate': '2014-04-02', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2009-10-22', 'dispFirstSubmitQcDate': '2014-04-02', 'studyFirstSubmitQcDate': '2009-10-23', 'dispFirstPostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety of a single topical dose of PRT-201.', 'timeFrame': 'Day of AVG creation and 4 weeks After surgery.'}], 'secondaryOutcomes': [{'measure': 'Primary graft patency', 'timeFrame': '3, 6, 9 and 12 months after AVG creation.'}, {'measure': 'Secondary graft patency.', 'timeFrame': '3, 6, 9 and 12 months after AVG creation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Arteriovenous Grafts (AVG)', 'Hemodialysis', 'Vascular Access', 'Dialysis', 'Graft', 'Access', 'vonapanitase', 'kidney', 'renal'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '24811601', 'type': 'RESULT', 'citation': '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 arteriovenous grafts in patients with chronic kidney disease. J Vasc Access. 2014 Sep-Oct;15(5):376-84. doi: 10.5301/jva.5000235. Epub 2014 May 3.'}, {'pmid': '34298589', 'type': 'DERIVED', 'citation': 'Mohamed I, Kamarizan MFA, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2021 Jul 23;7(7):CD002786. doi: 10.1002/14651858.CD002786.pub4.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age of at least 18 years.\n2. Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.\n3. Planned creation of a new upper extremity AVG or "jump" graft\n\nExclusion Criteria:\n\n1. Patients for whom this is the only potential site for an upper extremity vascular access.\n2. 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.\n3. 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.\n4. History or presence of an arterial aneurysm.\n5. Previous treatment with PRT-201.'}, 'identificationModule': {'nctId': 'NCT01001351', 'acronym': 'PRT-201-102', 'briefTitle': 'A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Proteon Therapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PRT-201-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PRT-201', 'interventionNames': ['Drug: PRT-201']}], 'interventions': [{'name': 'PRT-201', 'type': 'DRUG', 'description': 'Applied topically during surgery.', 'armGroupLabels': ['PRT-201']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Applied topically during surgery', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Ladenheim Dialysis Access Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'California Institute of Renal Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital/Medstar Research', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana/Ohio Heart', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University/Purdue University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Vascular Specialty Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Memorial Hospital', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78205', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Peripheral Vascular Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Vascular Specialists', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Marco Wong, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Proteon Therapeutics, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Proteon Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}