Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01871467
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years \< 80 years with diagnosis of end stage renal disease and currently undergoing outpatient hemodialysis (HD) at one of the Johns Hopkins University-affiliated HD units
Exclusion Criteria:
* Age\<18or\>80years
* History of non-adherence to prescribed HD treatment
* Active drug or heavy alcohol use (defined as \> 4 drinks/day)
* Pregnancy or breast feeding
* Active infection (bacterial or viral) or clinically significant infections within the past three months (e.g. those requiring hospitalization, or as judged by the PI)
* Active malignancy (with the exception of excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or adequately treated pre- invasive cervical cancer in situ)
* Unstable cardiovascular status (angina, arrhythmias, congestive heart failure etc...)
* History of liver disease (as defined by a diagnosis of uncompensated cirrhosis) • History of lung disease (including moderate-severe chronic obstructive pulmonary disease, interstitial lung disease, or asthma)
* Known hypersensitivity to yeast-derived products
* Hemoglobin \< 10 g/dL and hematocrit \< 30%.
* Abnormal white blood cell (WBC) count at baseline (\< 3 or \> 12 x 10 cells/mm )
* Treatment with WBC growth factors (G-CSF or GM-CSF) or immunosuppressive medications (tacrolimus, cyclosporine, mycophenolate, azathioprine, corticosteroids, chlorambucil, cyclophosphamide) within 4 weeks of study (erythropoiesis-stimulating agents will be allowed)
* Treatment with lithium within 4 weeks of study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01871467
Study Brief:
Protocol Section:
NCT01871467