Status:
WITHDRAWN
Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type I Diabetes
Eligibility:
All Genders
8-18 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled phase 2 study. Specific aim is to evaluate feasibility and safety of anti-IL-1 (interleukin 1) treatment in the course of standard therapy for di...
Detailed Description
Anakinra is a fully human IL-1ra (interleukin 1 receptor agonist) licensed in 2001 by FDA for the treatment of rheumatoid arthritis. It competitively binds to the IL-1 receptor, thus blocking IL-1 sig...
Eligibility Criteria
Inclusion
- Age 8-18 years at diagnosis of type 1 diabetes
- Diabetic ketoacidosis with:
- plasma glucose concentration \>300 mg/dl,
- venous pH \<7.30 or
- serum bicarbonate concentration \<15 mmol/L, and
- ketones in urine or serum
- Hematology:
- WBC \>3000 x 109/L;
- platelets \>100,000 x 109/L;
- hemoglobin \>10.0 g/dL
- Negative blood pregnancy test in females.
Exclusion
- Children with underlying disorders, including:
- active autoimmune or immune deficiency disorder other than type 1 diabetes,
- malignancy,
- organ transplant,
- any condition requiring chronic corticosteroid use
- Previous immunotherapy to prevent type 1 diabetes
- Current or prior infection with HIV, hepatitis B or hepatitis C assessed by history
- Patients who present with DKA concomitant with alcohol or drug use,
- Head trauma,
- Meningitis or other conditions which might affect neurological function
- Renal failure
- Any condition, medical or otherwise that would, in the opinion of the investigator, prevent complete participation in the study, or that would pose a significant hazard to the subject's participation
- Patients with a history of known hypersensitivity to:
- E coli-derived proteins,
- anakinra, or
- any components of the investigational drug product
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01477476
Start Date
March 1 2012
End Date
April 22 2016
Last Update
April 18 2019
Active Locations (2)
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1
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
2
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States, 80045