Sargramostim for Myeloid Dendritic Cell Deficiency

Phase 1

Completed

• Conditions: Dendritic Cell Deficiency
• Interventions: Drug: Sargramostim

• Registration Number: NCT01871467
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sargramostim administration	Sargramostim	Subjects will receive sargramostim.

Primary Outcome Measures

Name	Time	Method
Target blood myeloid dendritic cell level of > 2.0 x 10<4>/mL	2-4 weeks

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States