Sargramostim for Myeloid Dendritic Cell Deficiency

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