Sargramostim for Myeloid Dendritic Cell Deficiency

Sargramostim for Myeloid Dendritic Cell Deficiency - Phase I

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01871467

Enrollment

Registered

2013-06-06

Start date

2013-05-31

Completion date

2014-06-30

Last updated

2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dendritic Cell Deficiency

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.

Interventions

DRUGSargramostim

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026