Actively Recruiting
Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs
Led by Edward Geissler · Updated on 2024-05-16
300
Participants Needed
9
Research Sites
286 weeks
Total Duration
On this page
Sponsors
E
Edward Geissler
Lead Sponsor
C
Chiesi Pharmaceuticals GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated written informed consent
- Adults 18 years or older
- Renal insufficiency requiring first or second kidney transplant
- ABO blood type compatible with the donor kidney
- Able to swallow tacrolimus tablets or capsules orally
You will not qualify if you...
- Undergoing multi-organ transplantation
- History of solid organ transplant other than first kidney transplant
- For second kidney transplant recipients, first transplant lost within 2 years due to immune reasons or disease recurrence
- Patient or donor positive for HCV, HBV, or HIV
- History of malignancy not curatively treated
- Ongoing drug or alcohol abuse
- Signs of advanced liver disease or liver failure
- Uncontrolled systemic infection
- Severe gastrointestinal disorders affecting tacrolimus absorption
- Planned or expected use of cyclosporine, belatacept, or other tacrolimus preparations besides Envarsus or Advagraf
- Known allergy or intolerance to tacrolimus or related substances
- Pregnant or breastfeeding women
- Women of childbearing potential not using highly effective contraception
- Participation in another interventional trial within 4 weeks before or during this trial
- Any condition risking participant safety or study compliance
- Unable to provide informed consent, such as individuals under legal guardianship
AI-Screening
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Trial Site Locations
Total: 9 locations
1
University Hospital Aachen, Department of General, Visceral and Transplant Surgery
Aachen, Germany, 52074
Not Yet Recruiting
2
Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care
Berlin, Germany, 10117
Not Yet Recruiting
3
University Hospital Dresden, Division of Nephrology
Dresden, Germany, 01307
Actively Recruiting
4
University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology)
Hamburg, Germany, 20251
Actively Recruiting
5
Hannover Medical School, Department of General, Visceral and Transplant Surgery
Hanover, Germany, 30625
Actively Recruiting
6
University Hospital Jena, Internal Medicine III, Nephrology
Jena, Germany, 07747
Actively Recruiting
7
University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology)
Mainz, Germany, 55131
Not Yet Recruiting
8
University Hospital Münster, Medical Clinic D
Münster, Germany, 48149
Not Yet Recruiting
9
University Hospital Regensburg, Department of Nephrology
Regensburg, Germany, 93053
Actively Recruiting
Research Team
E
Edward K. Geissler, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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