NCT03063242

Sargramostim for Myeloid Dendritic Cell Deficiency

Sargramostim to Reverse Myeloid Dendritic Cell Deficiency

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

The overall objective of this project is to study the ability of sargramostim to enhance mDC level and function, including subsequent stimulation of T cell responses, in various human subjects with demonstrated myeloid dendritic cell (mDC) and T cell deficiency. Single center nonrandomized trial with an interrupted time series design involving measures on blood samples from three separate populations before and after administration of sargramostim. The objective is to determine the safety and dose response of sargramostim administration in healthy participants and in patients with chronic kidney disease (CKD) and kidney transplants. Additionally to determine whether reversal of mDC/T cell deficiency by sargramostim results in augmented T cell responses in these three groups.

Conditions

• Kidney Diseases
• Kidney Transplant

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-02-23
• Primary completion: 2018-09-17
• Completion: 2018-09-17
• First posted: 2017-02-24
• Last updated: 2018-12-31

Locations

1 site across 1 country: United States