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Clinical Trial Details

Trial ID: L5927
Source ID: NCT02083991
Associated Drug: Steroid-Free Low Tac-Arm: Thymoglobulin Standard Low-Tac Arm: Simulect, Prednisolon
Title: Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation
Acronym: SAILOR
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon
Outcome Measures: Primary: Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT), 12 month after transplantation | Secondary: Cumulative incidence of NODAT, 3, 6, 24 month after transplantation|Composite measure, Freedom from acute rejection, graft and patient survival, 12, 24 months|Renal function, Evaluated by measured glomerular filtration rate (mGFR), 12, 24 months|Incidence of acute rejection and chronic changes, Analysed by protocol biopsies, evaluated by the Banff system., 12 months|Incidence of hypertension, Standardized measurement., 3, 12, 24 months|Antihypertensive treatment, Number and type of antihypertensive drugs., 3, 12, 24 months|Lipid lowering drugs, Number and type of lipid lowering drugs., 12, 24 months|Incidence of antibody-mediated rejection, Analysed by biopsies, evaluated by the Banff system, and by donor-specific HLA antibodies, 12, 24 months|Cumulative frequency of cardiovascular complications and events., Collecting Adverse Events (AE) reports, 10 days, 3, 12, 24 months|Cumulative frequency of malignancy., Collecting AE reports, 6, 12, 24 months|Cumulative frequency of infections, Collecting AE reports, 10 days, 3, 6, 12, 24 months
Sponsor/Collaborators: Sponsor: Vastra Gotaland Region
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 224
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-01
Completion Date: 2017-12
Results First Posted:
Last Update Posted: 2021-01-05
Locations: Transplant Institute, Sahlgrenska University Hospital, Gothenburg, 41345, Sweden
URL: https://clinicaltrials.gov/show/NCT02083991