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Clinical Trial Details

Trial ID: L0579
Source ID: NCT06701825
Associated Drug: Tacrolimus
Title: Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus
Acronym: TRANSPGx
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Kidney Disease, Chronic|Transplant Recipient (Kidney)|Immunosuppression
Interventions: DRUG: Tacrolimus|DRUG: Tacrolimus
Outcome Measures: Primary: Tacrolimus concentrations levels, Number and percentage of patients achieving tacrolimus target plasma concentrations at visit 3. Tacrolimus concentrations levels at day 4 (+/-1d) will be the effectiveness surrogate outcome. It will be considered therapeutic range levels between 7-10 ng/ml., 4 days | Secondary: Incremental cost-effectiveness ratio (ICER), Cost-effectiveness ratio that divides the differences in costs between both treatments by the difference in effectiveness between both treatments., Though study completion, on average 18 months|Number and percentage of patients with transplant rejection., Transplant rejection will be considered if there is histological confirmation and/or the patient initiates any type of therapy aimed at treating rejection (e.g. corticosteroids)., Though study completion, on average 18 months|Rate of AE associated to treatment., All adverse events associated to tacrolimus will be recorded during the study, Though study completion, on average 18 months|Number and percentage of patients achieving tacrolimus target plasma concentrations at visit 4, 5 and 6., Week 4, 15 and 26|Healthcare expenditure related to predefined events of interest, Any costs made as a result of an AE, Though study completion, on average 18 months|Incidence of discontinuation or treatment modification, Incidence of discontinuation or treatment modification due to lack of effective related to the drug of inclusion., Though study completion, on average 18 months | Other: Novel prognostic and predictive genetic biomarkers of tacrolimus safety and effectiveness, All participants DNA sample will be susceptible of deep sequencing analysis assessed trough techniques only available at Nation Centre of Oncological Investigations (CNIO) and genome-wide association studies when applicable, Though study completion, on average 18 months|Identification of new actionable genes/relevant polymorphisms within the predefined population subsets, Though study completion, on average 18 months
Sponsor/Collaborators: Sponsor: Instituto de Investigación Hospital Universitario La Paz | Collaborators: Instituto de Salud Carlos III
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 160
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2025-02-01
Completion Date: 2026-10-31
Results First Posted:
Last Update Posted: 2024-12-03
Locations: Hospital La Paz, Madrid, Comunidad De Madrid, 28046, Spain
URL: https://clinicaltrials.gov/show/NCT06701825