Kidney Transplantation Clinical Trial
Official title:
An Open-label, Single-centre Study to Assess the Effect of Food on the Relative Bioavailability of Orally Administered Tacrolimus Modified Release Formulation, FK506E (MR4), in Stable Kidney Transplant Recipients
The purpose of this study is to evaluate the effect of food on the oral bioavailability of tacrolimus modified release (MR4) capsules together with a standard continental breakfast. The objective is to assess the pharmacokinetics and relative bioavailability with and without food.
Stable kidney transplant recipients who are participating in the clinical trial FG-506-14-02
and who are currently being treated with FK506E (MR4) under fasted conditions and who have
had no changes in any of their medications for at least seven days will be enrolled in the
sub-study. Following enrolment, all patients will remain on all their medication and the
same dosing regimen throughout the study.During the study two 24 hour blood concentration
time profiles will be collected, each one on the last day of Period 2 and Period 3 of the
sub-study as follows:
Profile 1 on Day 7 under fasted conditions
Profile 2 on Day 14 under non-fasted conditions
A total of five scheduled visits are planned.
At least 24 patients with two complete, evaluable profiles are needed to estimate the effect
of food on the oral bioavailability of FK506E (MR4).
Blood sampling - For each sample a 2 mL aliquot of whole blood will be collected. The total
blood volume for the two profiles taken per patient will be approximately 40 mL.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04910867 -
APOL1 Genetic Testing Program for Living Donors
|
N/A | |
| Completed |
NCT02723591 -
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
|
Phase 4 | |
| Completed |
NCT05945511 -
Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
|
||
| Completed |
NCT02234349 -
Bile Acids and Incretins in Pancreas Kidney Transplant Patients
|
N/A | |
| Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 | |
| Recruiting |
NCT05917795 -
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
|
N/A | |
| Not yet recruiting |
NCT05934383 -
Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
|
N/A | |
| Withdrawn |
NCT04936971 -
Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response
|
Phase 4 | |
| Not yet recruiting |
NCT04540640 -
Oxygenated Machine Preservation in Kidney Transplantation
|
N/A | |
| Not yet recruiting |
NCT03090828 -
Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease
|
N/A | |
| Recruiting |
NCT02908139 -
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients
|
N/A | |
| Terminated |
NCT02417870 -
Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation
|
Phase 1/Phase 2 | |
| Completed |
NCT02560558 -
Bela 8 Week Dosing
|
Phase 4 | |
| Recruiting |
NCT02154815 -
Pre-emptive Kidney Transplantation Quality of Life
|
N/A | |
| Completed |
NCT02235571 -
iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
|
N/A | |
| Enrolling by invitation |
NCT01905514 -
ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients
|
N/A | |
| Completed |
NCT02147210 -
Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1
|
N/A | |
| Recruiting |
NCT01699360 -
The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients
|
Phase 4 | |
| Terminated |
NCT01436305 -
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
|
Phase 2 | |
| Completed |
NCT01672957 -
ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil)
|
N/A |