Condition: Immunosuppression · Sponsor: Edward Geissler
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.
This description comes directly from the study's public registry record.
Edward K. Geissler, PhD · +49 941 944 · edward.geissler@ukr.de
Always discuss trial participation with your own doctor first.
| University Hospital Aachen, Department of General, Visceral and Transplant Surgery | Aachen, Germany | Not Yet Recruiting |
| Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care | Berlin, Germany | Not Yet Recruiting |
| University Hospital Dresden, Division of Nephrology | Dresden, Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology) | Hamburg, Germany | Recruiting |
| Hannover Medical School, Department of General, Visceral and Transplant Surgery | Hanover, Germany | Recruiting |
| University Hospital Jena, Internal Medicine III, Nephrology | Jena, Germany | Recruiting |
| University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology) | Mainz, Germany | Not Yet Recruiting |
| University Hospital Münster, Medical Clinic D | Münster, Germany | Not Yet Recruiting |
| University Hospital Regensburg, Department of Nephrology | Regensburg, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06268769