Renal Transplantation Clinical Trial
Official title:
Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation
A pharmacokinetics and pharmacogenetics study to complement the current knowledge of
tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at
steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on
tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after
renal transplantation.
Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus
immediate release (Prograf®)
Multicentre open-labeled randomized pharmacokinetic (PK) and pharmacogenetic (PG) study to
compare Advagraf and Prograf immediate post-transplantation (Day 8) and steady-state (Day
84) systemic exposure.
Tacrolimus PK profile, tacrolimus systemic exposure assessed by Limited Samples Strategies
(LSS) (i.e.: Bayesian estimators (BE) and Multilinear Regressions (MLR)), and impact of
CYP3A5 and ABCB1 genetic polymorphisms on tacrolimus PK will also be determined to improve
the optimal dose of Advagraf® for kidney transplant patients.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06026592 -
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
|
||
| Active, not recruiting |
NCT02444429 -
3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation
|
Phase 3 | |
| Completed |
NCT02238418 -
Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.
|
Phase 4 | |
| Completed |
NCT01729494 -
Belatacept Early Steroid Withdrawal Trial
|
Phase 4 | |
| Terminated |
NCT01436305 -
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
|
Phase 2 | |
| Completed |
NCT02843295 -
Catalytic Antibodies to Predict Uninvasively Late Transplant Failure
|
N/A | |
| Terminated |
NCT01276834 -
Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation
|
Phase 4 | |
| Completed |
NCT00842699 -
Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
|
N/A | |
| Completed |
NCT00525681 -
Interaction Between Rimonabant and Cyclosporine and Tacrolimus
|
Phase 4 | |
| Completed |
NCT00776750 -
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
|
Phase 4 | |
| Completed |
NCT00189735 -
A Study to Evaluate FK778 in Kidney Transplant Patients
|
Phase 2 | |
| Recruiting |
NCT04052867 -
Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy
|
N/A | |
| Recruiting |
NCT03114826 -
Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients
|
N/A | |
| Completed |
NCT02587052 -
A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
|
||
| Completed |
NCT02020642 -
Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)
|
N/A | |
| Recruiting |
NCT01001065 -
Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis
|
N/A | |
| Completed |
NCT00978965 -
Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs
|
||
| Recruiting |
NCT00903188 -
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
|
Phase 4 | |
| Completed |
NCT00425308 -
Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.
|
Phase 3 | |
| Completed |
NCT00400400 -
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
|
Phase 4 |