Influence of split corticosteroid dose on glucose metabolism in patients with autoimmune kidney disease

Phase 1

• Conditions: ANCA vasculitis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-002068-29-AT
• Lead Sponsor: Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-12
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

•Informed consent obtained after being advised of the nature of the study
•Male or female aged 18-80 years (both inclusive)
•Newly diagnosed ANCA vasculitis with involvement of the kidney requiring high-dose corticosteroid therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

•Pre-existing diabetes mellitus
•Continuous parenteral nutrition
•Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods during the study
•History of bleeding disorder
•Current participation in another clinical study
•Significant acute or chronic illness that may interfere with subject safety or integrity of results as judged by the investigator
•Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen
•Any mental condition rendering the patient incapable of giving his/her consent
•Known or suspected allergy to insulins glargine, aspart, glulisine or lispro

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified