Sargramostim for Myeloid Dendritic Cell Deficiency
Kidney Diseases, Kidney Transplant

About this trial
This is an interventional treatment trial for Kidney Diseases focused on measuring Sargramostim
Eligibility Criteria
Inclusion Criteria:
- Age >18 years < 80 years
- Absence of acute or chronic medical condition and taking no prescription medications (Project I)
- Stable native or transplant kidney function (Project II/III)
Exclusion Criteria:
- Age < 18 or > 80 years
- History of non-adherence to prescribed medications (Projects II and III)
- 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, except for CMV viremia in Project III)
- 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 (CHF) etc…)
- History of liver disease (as defined by a diagnosis of uncompensated cirrhosis)
- History of lung disease (including moderate-severe Chronic Obstructive Pulmonary Disease (COPD), interstitial lung disease, or asthma)
- Known hypersensitivity to yeast-derived products
- Hemoglobin < 10 g/dL and hematocrit < 30%.
- Abnormal white blood cell count (WBC) count at baseline (< 3 or > 12 x 103 cells/mm3, except Project III)
- 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 for Project II and immunosuppression for Project III)
- Treatment with lithium within 4 weeks of study
- History of arterial or venous thrombosis
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Project I: Healthy participants
Project II: Patients with CKD stage IV/V
Project III: kidney transplant patients
5 healthy participants will be used to optimize the dosage and timing of sargramostim administration with regard to the primary and secondary outcomes. Blood samples will be drawn and analyzed for mDC levels.
5 Patients with CKD stage IV/V who are cytomegalovirus (CMV) seropositive with mean blood mDC levels <1.0x104/mL will receive sargramostim treatment once all 5 healthy participants have completed treatment and the data have been analyzed to guide subsequent dosing. Blood samples will be drawn and analyzed for mDC levels.
5 Kidney transplant recipients who are CMV seropositive with neutropenia (defined as absolute neutrophil count <1.0 x103/mm3) and/or CMV viremia will receive sargramostim treatment once all 5 Project I participants have completed treatment and the data have been analyzed to guide subsequent dosing. Blood samples will be drawn and analyzed for mDC levels.