Sargramostim for Myeloid Dendritic Cell Deficiency

NCT03063242 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-12-31

No results posted yet for this study

Summary

The study will determine whether administration of sargramostim will improve myeloid dendritic cell deficiency in various study groups, including healthy subjects and patients with chronic kidney disease, including those with kidney transplants.

Conditions

Interventions

DRUG

Sargramostim

Study participants (n=5 per project) will receive subcutaneous injection of sargramostim (6 ug/kg) daily until maximal mDC levels are achieved, as determined by a dose response curve.

BIOLOGICAL

Blood samples

Blood samples will be drawn at baseline and during each subsequent visit

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Karl Womer, MD · University of Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-23
Primary Completion
2018-09-17
Completion
2018-09-17

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063242 on ClinicalTrials.gov