ANCA vasculitis
Conditions
Interventions
Trade Name: Aprednislon
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of splitting the total daily corticosteroid dose in two equal corticosteroid doses in patients with ANCA vasculitis ;Secondary Objective: Safety To investigate the safety of splitting the total daily corticosteroid dose in two equal corticosteroid doses in patients with ANCA vasculitis Efficacy To investigate further efficacy parameters of dividing the total daily corticosteroid dose in two equal corticosteroid doses in patients with ANCA vasculitis ;Primary end point(s): Mean percentage of time in target (70-140mg/dl) assessed by blinded continuous glucose monitoring (CGM);Timepoint(s) of evaluation of this end point: Following study completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Number and percentage of glucose measurements (CGM, BG) in the following ranges: 0-140-180mg/dl, 180-140-180mg/dl, 180-<300mg/dl, = 300mg/dl •Mean daily blood glucose as calculated by premeal and bedtime glucose values: overall and per treatment day •Mean pre-breakfast BG, mean pre-lunch BG, mean pre-dinner BG and mean bedtime BG •Pre-enrolment HbA1c •Mean pre-enrolment BG •Number of additionally required BG measurements •Number of insulin injections per day •Daily insulin dose (basal, bolus, total) •Relevant concomitant medication (corticosteroids, parenteral nutrition, antibiotics, oral hypoglycemic agents) •Relevant medication at time of hospital discharge (insulin therapy – type and dose, oral hypoglycemic agents) •Post-discharge diabetes therapy (insulin therapy – type and total daily dose, oral hypoglycemic agents) •HbA1c •Adverse events •Corticosteroid dose •Body weight and BMI •Hypoglycemic events •Birmingham Vasculitis Score (BVAS) •Serum-Creatinine and glomerular filtration rate evaluated by the CKD-EPI formula •Albuminuria (Urinary Albumin/Creatinine Ratio) •Erythrocytes and casts in the urinary sediment •Quality of life assessment by SF-36 questionnaire ;Timepoint(s) of evaluation of this end point: Following study completion | — |
Countries
Austria
Contacts
Public ContactDiabetes Studienambulanz
Medizinische Universität Graz
Outcome results
None listed