Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes

• Status: Withdrawn
• Trial end date: 2016-04-22
• Target enrollment: 0
• Participant gender: All

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 diabetic ketoacidosis in children and its effect on intracranial pressure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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