Sargramostim for Myeloid Dendritic Cell Deficiency

Stopped early · Phase 2

Conditions studied: Kidney Diseases, Kidney Transplant

In brief

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.

Key facts

Study ID

NCT03063242

Run by

University of Florida

People needed

4

Starts

2017-02-23

Expected to finish

2018-09-17

Last updated by the study team

2018-12-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age >18 years < 80 years
• Absence of acute or chronic medical condition and taking no prescription medications (Project I)
• Stable native or transplant kidney function (Project II/III)

You may not qualify if…

• Age < 18 or > 80 years
• History of non-adherence to prescribed medications (Projects II and III)
• 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, except for CMV viremia in Project III)
• 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 (CHF) etc…)
• History of liver disease (as defined by a diagnosis of uncompensated cirrhosis)
• History of lung disease (including moderate-severe Chronic Obstructive Pulmonary Disease (COPD), interstitial lung disease, or asthma)
• Known hypersensitivity to yeast-derived products
• Hemoglobin < 10 g/dL and hematocrit < 30%.
• Abnormal white blood cell count (WBC) count at baseline (< 3 or > 12 x 103 cells/mm3, except Project III)
• 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 for Project II and immunosuppression for Project III)
• Treatment with lithium within 4 weeks of study
• History of arterial or venous thrombosis

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.