Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief Summary: 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.


Options:
A: Inclusion Criteria:

1. Age of at least 18 years.
2. Life expectancy of at least 6 months.
3. Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
4. Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.

Exclusion Criteria:

1. History or presence of an arterial aneurysm.
2. 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 cancer, squamous cell skin cancer, or any cancer in situ.
3. Hepatic dysfunction defined as bilirubin, ALT \[SGPT\] or AST \[SGOT\] \>2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices.
4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
B: Inclusion criteria:

* Age 18-21 depending on state regulations
* Life expectancy of at least six months
* Chronic renal failure with anticipated start of hemodialysis within six months of enrollment, or current dialysis dependence
* A new or planned arteriovenous (AV) graft placed in any location for the purpose of hemodialysis. (Any type of graft material and any configuration of the access is acceptable).
* The patient is expected to stay at a participating dialysis facility for at least 6 months.
* The patient's physician(s) will allow the patient to participate.
* Ability to give informed consent.

Exclusion Criteria:

* Women must not be pregnant, breastfeeding, or plan to be pregnant during the course of the study.
* The presence of ongoing bleeding.
* The presence of a known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
* Recent bleeding episode requiring transfusion within 12 weeks of entry.
* The presence of acute ulcer disease. Acute ulcer disease is defined as a new diagnosis of peptic disease including esophagitis, gastritis, or ulcer or the initiation of treatment with proton pump inhibitors, H2 blockers or therapy for Helicobacter pylori within three months prior to obtaining consent.
* Known allergy or adverse reaction to Aggrenox or any of its study components (dipyridamole and aspirin).
* Required use of warfarin, dipyridamole, non-steroidal antiinflammatory drugs or other antiplatelet agents other than aspirin.
* Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hg or diastolic blood pressure in excess of 115 mm Hg.
* Baseline platelet count less than 75,000/mm3.
* Known advanced liver disease with decompensated cirrhosis, jaundice, ascites or bleeding varices.
* Current problem with substance abuse.
* Concurrent participation in another medical intervention trial.
* Anticipated non-compliance with medical care based on physician judgment.
* Patient refusal.
C: 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.
D: 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.

Answer: D