Status:
COMPLETED
Sargramostim for Myeloid Dendritic Cell Deficiency
Lead Sponsor:
Johns Hopkins University
Conditions:
Dendritic Cell Deficiency
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01871467
Start Date
May 1 2013
End Date
June 1 2014
Last Update
August 22 2017
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205