| Trial ID: | L2069 |
| Source ID: | NCT01477476
|
| Associated Drug: |
Anakinra
|
| Title: |
Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type I Diabetes
|
| Interventions: |
DRUG: Anakinra|OTHER: Placebo Comparator
|
| Outcome Measures: |
Primary: Frequency of Adverse Events, Type and number of Adverse Events related to anti-IL-1 treatment (anakinra) during the initial 24 hour period of DKA treatment., 24 hours |
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-03
|
| Completion Date: |
2016-04-22
|
| Results First Posted: |
|
| Last Update Posted: |
2019-04-18
|
| Locations: |
Childrens Hospital Colorado, Aurora, Colorado, 80045, United States|University of Colorado, Anschutz Medical Campus, Aurora, Colorado, 80045, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01477476
|
