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Completed

NCT Number: NCT01871467

Sargramostim for Myeloid Dendritic Cell Deficiency

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 plan to test the ability of sargramostim to increase blood dendritic cell levels in patients with kidney disease in the hopes of developing new therapies to prevent viral infections after kidney transplantation.

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Key information

Conditions

Dendritic Cell Deficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Sargramostim

Drug

Primary outcomes

  1. Target blood myeloid dendritic cell level of > 2.0 x 10<4>/mL

    Time frame: 2-4 weeks

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Sargramostim for Myeloid Dendritic Cell Deficiency - Phase I

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2013
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.