A Phase 2 interventional study of Sargramostim and Blood samples in Kidney Diseases and Kidney Transplant, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-31.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 4 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5 healthy participants will be used to optimize the dosage and timing of sargramostim administration with regard to the primary and secondary outcomes. Blood samples will be drawn and analyzed for mDC levels.
Drug: Sargramostim · Biological: Blood samples
5 Patients with CKD stage IV/V who are cytomegalovirus (CMV) seropositive with mean blood mDC levels \<1.0x104/mL will receive sargramostim treatment once all 5 healthy participants have completed treatment and the data have been analyzed to guide subsequent dosing. Blood samples will be drawn and analyzed for mDC levels.
Drug: Sargramostim · Biological: Blood samples
5 Kidney transplant recipients who are CMV seropositive with neutropenia (defined as absolute neutrophil count \<1.0 x103/mm3) and/or CMV viremia will receive sargramostim treatment once all 5 Project I participants have completed treatment and the data have been analyzed to guide subsequent dosing. Blood samples will be drawn and analyzed for mDC levels.
Drug: Sargramostim · Biological: Blood samples
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.
Also known as: Leukine®, GM-CSF
Blood samples will be drawn at baseline and during each subsequent visit
Change in peripheral blood mDC levels
mDC levels to \>2.0 x104 mDCs/mL, with the target level defined as levels at or above upper quartile values in healthy controls
Time frame: Baseline to 2 weeks
Proportion of patients with adverse events during the intervention.
Time frame: Baseline to 2 weeks
Increase in T cell levels, mDC Interleukin (IL)-12 production, and interferon-gamma (IFN-y) production in QuantiFERON-CMV and QuantiFERON-Monitor assays after the intervention.
Time frame: Baseline to 2 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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