Sargramostim for Myeloid Dendritic Cell Deficiency

NCT01871467 | Completed Phase 1

• 1 other identifier: KW-5001-1
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dendritic Cell Deficiency

Outcome Measures

Primary Outcomes (1)

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

  2-4 weeks

Study Arms (1)

Sargramostim administration

EXPERIMENTAL

Subjects will receive sargramostim.

Drug: Sargramostim

Interventions

Sargramostim DRUG

Sargramostim administration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Interventions

sargramostim

Study Officials

• Karl L Womer, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)