Sargramostim for Myeloid Dendritic Cell Deficiency

Overview

Previous studies have demonstrated a deficiency of blood dendritic cells in patients with kidney disease that is associated with the development of viral infections after kidney transplantation. We plan to test the ability of sargramostim to increase blood dendritic cell levels in patients with kidney disease in the hopes of developing new therapies to prevent viral infections after kidney transplantation.

Full Title of Study: “Sargramostim for Myeloid Dendritic Cell Deficiency – Phase I”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Other
  • Masking: None (Open Label)
• Study Primary Completion Date: June 2014

Interventions

• Drug: Sargramostim

Arms, Groups and Cohorts

• Experimental: Sargramostim administration
  • Subjects will receive sargramostim.

Clinical Trial Outcome Measures

Primary Measures

• Target blood myeloid dendritic cell level of > 2.0 x 10<4>/mL
  • Time Frame: 2-4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Johns Hopkins University
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Karl L Womer, MD, Principal Investigator, Johns Hopkins University