Sargramostim for Myeloid Dendritic Cell Deficiency

• Status: Terminated
• Trial end date: 2018-09-17
• Target enrollment: 0
• Participant gender: All

Summary

The study will determine whether administration of sargramostim will improve myeloid dendritic cell deficiency in various study groups, including healthy subjects and patients with chronic kidney disease, including those with kidney transplants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Treatments: Sargramostim

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