Sargramostim for Myeloid Dendritic Cell Deficiency

NCT ID: NCT01871467

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-06-30

Brief Summary

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.

Conditions

Dendritic Cell Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sargramostim administration

Subjects will receive sargramostim.

Group Type: EXPERIMENTAL

Sargramostim

Intervention Type: DRUG

Interventions

Sargramostim

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl L Womer, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

KW-5001-1

Identifier Type: -

Identifier Source: org_study_id