Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo
Brief Summary: This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.


Options:
A: Inclusion Criteria:

1. Patients with end stage renal disease requiring chronic renal replacement therapy
2. Age ≥ 18 years,
3. Achieved mean eKt/V of ≥ 1.1 during Baseline

Exclusion Criteria:

1. GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
2. Expectation that native kidneys will recover kidney function
3. Current access is temporary non-tunneled catheter
4. Unable to follow the nocturnal home hemodialysis training protocol for any reason, including inability to train the patient or the patient's caregiver
5. Non-compliance with hemodialysis or peritoneal dialysis treatments in the past
6. Medical conditions that would prevent the patient from performing the cardiac MRI procedure (e.g., inability to remain still for the procedure, a metallic object in the body, including cardiac pacemaker, inner ear (cochlear) implant, brain aneurysm clips, mechanical heart valves, recently placed artificial joints, and older vascular stents)
7. Unable to verbally communicate in English or Spanish
8. Current requirement for hemodialysis more than three times per week due to medical comorbidity (ultrafiltration session on fourth day per week not an exclusion criteria)
9. Currently on daily or nocturnal HD, or less than 3 months since the patient discontinued daily or nocturnal HD
10. Scheduled for living donor kidney transplant, change to peritoneal dialysis, or plans to relocate to an area outside of the referral area of one of the Clinical Centers within the next 12 months
11. Expected geographic unavailability at the Clinical Center (for standard arm patients) or at home (for nocturnal arm patients) for \> 2 consecutive weeks or \> 5 weeks total during the next 12 months (excluding unavailability due to hospitalizations)
12. Less than 3 months since the patient returned after acute rejection resulting in allograft failure
13. Currently in acute care or chronic care hospital
14. Life expectancy less than six months
15. A medical history that might limit the individual's ability to take trial treatments for the 12 month duration of the study, including: currently receiving chemo or radiotherapy for a malignant neoplastic disease other than localized non-melanoma skin cancer, active systemic infection (including tuberculosis, disseminated fungal infection, active AIDS but not HIV), and cirrhosis with encephalopathy
16. Current pregnancy or planning to become pregnant within the next fourteen months (patients require a higher dose of dialysis if pregnant). All female patients that have not gone through menopause will need to use an effective contraceptive method while enrolled in the study.
17. Contraindication to heparin, including allergy or heparin induced thrombocytopenia
18. Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
19. Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
20. Unable or unwilling to provide informed consent or sign IRB-approved consent form
B: Inclusion Criteria:

* Male or female patients \> 18 years.
* Have chronic kidney disease per K/DOQI guidelines.
* Baseline hemoglobin of \> 9.0 and \< 12.5 g/dl

Exclusion Criteria:

* Women who are pregnant or lactating.
* Received another investigational drug or device within 30 days.
* Recent parenteral or oral iron therapy.
* Patients that have other causes of anemia.
* Major surgery within 30 days or anticipated or planned surgery during the study.
* Patients with active infections.
* Recent blood transfusions.
* Patients with known allergies to iron products.
C: Inclusion Criteria:

* age greater than 18 years
* undergoing hemodialysis for 3 months or more or healthy control without kidney disease

Exclusion Criteria:

* inability to give informed consent
* diagnosis of diabetes mellitus
* musculoskeletal contraindication to exercise
* infection requiring intravenous antibiotics within 2 months
* hospitalization within 2 months
* ingestion of antioxidant supplements within one month
* requirement for systemic anticoagulation
* estimated GFR \<60 ml/min/1.73 m2 for healthy controls
D: Inclusion Criteria:

* Age ≥ 18 years
* Maintenance hemodialysis with hemodialysis vintage of at least 30 days
* Ability to read and understand the English language and give informed consent

Exclusion Criteria:

* Dialysis treatment frequencies other than three times per week
* Hospitalisations or antibiotics-dependent infection during the 8 weeks preceding enrollment
* Central venous catheter as hemodialysis access

Answer: B