Sargramostim for Myeloid Dendritic Cell Deficiency

Sargramostim for Myeloid Dendritic Cell Deficiency - Phase I

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.

Study Overview

• Status: Completed
• Conditions: Dendritic Cell Deficiency
• Intervention / Treatment: Drug: Sargramostim

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sargramostim administration; Subjects will receive sargramostim.	Drug: Sargramostim

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Karl L Womer, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: June 5, 2013
• First Posted (Estimate): June 6, 2013

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Sargramostim
• Other Study ID Numbers: KW-5001-1