nctId: NCT06268769 id: TaC:Drop id: 2023-503531-18-00 type: OTHER domain: EUCT Number briefTitle: Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs acronym: TaC:Drop overallStatus: RECRUITING date: 2024-03-09 date: 2026-12 date: 2029-09 date: 2024-02-20 date: 2024-04-08 name: Edward Geissler class: OTHER name: Chiesi Pharmaceuticals GmbH briefSummary: The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit. conditions: Immunosuppression studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A dynamic allocation technique assigns participants in a 1:1 ratio to one of two treatment arms: Envarsus tablets (test IMP) or Advagraf capsules (comparator IMP). Randomisation is stratified by two factors: a) trial site, in order to minimise systematic treatment bias at the level of the trial centre and reduce the influence of inter-centre variability, and b) participation in the optional pharmacokinetic sub-study, in order to ensure an equal representation of Envarsus- and Advagraf-treated patients in the sub-study. primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Tacrolimus Pill name: Tacrolimus capsule measure: Dose-normalised blood trough level of tacrolimus (concentration/dose ratio) measure: Time to reach the first trough level in target range measure: Proportion of patients with trough levels lower, within, or higher than the target range measure: Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels measure: Mean daily dose of tacrolimus and inter-patient variability (range) of tacrolimus daily dose measure: Tacrolimus concentration/dose (C/D) ratio measure: Intra-patient variability of C/D ratio and daily dose measure: Treatment failure rate measure: Time to treatment failure after transplantation measure: Incidence rate, severity and time to clinically-confirmed biopsy-proven acute rejection measure: Incidence rate of graft failure measure: Mortality rate measure: Graft function measured by eGFR (estimated glomerular filtration rate) measure: Incidence rate of for-cause biopsies measure: Incidence rate of acute rejection episodes requiring treatment measure: Incidence rate of steroid-resistant episodes of biopsy-proven acute rejection measure: Incidence rate of delayed graft function measure: Incidence rate of primary non-function of the renal allograft measure: Incidence of hepatotoxicity measure: Incidence of CMV and BKV infection (including organ manifestation, if relevant) measure: Incidence, type, severity and seriousness of adverse reactions (ARs) measure: Blood pressure measure: Incidence of de novo tremor measure: Incidence of gastrointestinal disorders requiring diagnostic investigation measure: Incidence of new onset diabetes mellitus after transplantation (NODAT) measure: Recurrence of primary kidney disease measure: Incidence of de novo DSA measure: Patient-reported health-related quality-of-life measured using the Kidney Transplant Questionnaire-34 (KTQ-34) measure: Doses and duration of glucocorticosteroid treatment measure: Dose of mycophenolate measure: Incidence and time to study treatment discontinuation measure: Incidence, time to and reason for patient withdrawal from study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care status: NOT_YET_RECRUITING city: Berlin zip: 10117 country: Germany name: Klemens Budde, Prof. Dr. role: CONTACT lat: 52.52437 lon: 13.41053 facility: University Hospital Dresden, Division of Nephrology status: RECRUITING city: Dresden zip: 01307 country: Germany name: Christian Hugo, Prof. Dr. role: CONTACT lat: 51.05089 lon: 13.73832 facility: University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology) status: NOT_YET_RECRUITING city: Hamburg zip: 20251 country: Germany name: Malte A. Kluger, PD Dr. role: CONTACT lat: 53.57532 lon: 10.01534 facility: University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology) status: NOT_YET_RECRUITING city: Mainz zip: 55131 country: Germany name: Julia Weinmann-Menke, Prof. Dr. role: CONTACT lat: 49.98419 lon: 8.2791 facility: University Hospital Regensburg, Department of Nephrology status: RECRUITING city: Regensburg zip: 93053 country: Germany name: Edward K. Geissler, PhD role: CONTACT phone: +49 941 944 phoneExt: 6961 email: edward.geissler@ukr.de name: Bernhard Banas, MD, PhD role: CONTACT phone: +49 941 944 phoneExt: 7301 email: bernhard.banas@ukr.de lat: 49.01513 lon: 12.10161 hasResults: False