Prednisolone for ANCA-associated vasculitis|Rapidly progressive glomerulonephritis

Inclusion criteria

• {"criterion_text":"- Written agreement to participate in the study after detailed explanation of the study\n- Male or female patients\n- New diagnosis of ANCA-associated vasculitis or a relapse of a known ANCA vasculitis\n- Age: ≥18-80 years at the time of biopsy\n- Aprednislon dose of 1mg/kg body weight at the time of inclusion\n- Wants to wear a CGM system for the duration of the study and to receive insulin therapy as needed"}

Exclusion criteria

• {"criterion_text":"- Known diabetes mellitus\n- Women capable of giving birth who are pregnant, breastfeeding, wish to become pregnant or do not use adequate contraception.\n- Skin changes or concomitant circumstances that prevent the placement of a glucose sensor in the examiner's assessment (e.g. scar tissue)\n- Current participation in another clinical trial that would affect study results\n- Relevant acute or chronic disease that, in the investigator's estimation, could affect the patient's safety or affect the study results.\n- Patient's inability to follow study procedures as required\n- Inability of the patient to understand the consent form"}

Primary endpoints

• {"endpoint_text":"- Mean time in target range (70-180mg/dl) measured by blinded continuous glucose measurement (CGM).","definition_or_measurement_approach":"Measured by blinded continuous glucose measurement (CGM); endpoint is mean time in target glucose range 70-180 mg/dL."}

Secondary endpoints

• {"endpoint_text":"- Number and percent of glucose values (CGM, BG) in the following ranges: 0-<40mg/dl (blood glucose only), 40-<70mg/dl, 70-<100mg/dl, 100-<140mg/dl, 140-<180mg/dl, 180-<300mg/dl, ≥300mg/dl\n- Time of glucose values (CGM, BG) in the following ranges: 0-<40mg/dl (blood glucose only), 40-<70mg/dl, 70-<100mg/dl, 100-<140mg/dl, 140-<180mg/dl, 180-<300mg/dl, ≥300mg/dl\n- Average daily blood glucose based on preprandial and bedtime glucose values: total and per treatment day\n- Mean blood glucose before the respective times: before breakfast, before lunch, before dinner, at bedtime\n- Mean blood glucose before start of study during in-patient stay\n- Number of insulin injections per day\n- Relevant concomitant medication during inpatient stay (corticosteroids, parenteral nutrition, oral antidiabetics)\n- Relevant diabetes medication for discharge from inpatient care (insulin therapy - type and dose, oral antidiabetics)\n- HbA1c\n- Sex\n- Age\n- Additionally affected organs\n- Antibody titer (ANCA, anti-GBM, anti-ds-DNS,..) at initial diagnosis and during course of disease\n- CRP at initial diagnosis and during course of treatment\n- Leukocytes at initial diagnosis and during course of disease\n- Thrombocytes at initial diagnosis and during course of disease\n- GFR at initial diagnosis and during course of disease\n- Creatinine at initial diagnosis and during course of disease\n- Protein and albuminuria at initial diagnosis and during course of disease\n- Urinary sediment at initial diagnosis and in the course of the disease\n- Therapy after initial diagnosis and during course (e.g. switch to rituximab)\n- Birmingham Vasculitis Score (BVAS) on discharge\n- Quality of life measured by the SF-36 and KDQOL questionnaire","definition_or_measurement_approach":"Endpoints measured using CGM and capillary blood glucose (BG) where specified; laboratory measures (HbA1c, CRP, leukocytes, thrombocytes, GFR, creatinine, protein/albuminuria, urinary sediment), antibody titers, insulin injection counts, concomitant medication records, BVAS score assessment on discharge, and QoL questionnaires (SF-36, KDQOL)."}

Austria

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

18-11-2024

Processing Time Days

119

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Medical University Of Graz

Organisation Type

Educational Institution

Country Of Registered Address

Austria