Clinical trials: Tacrolimus
Renal Transplant
Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
- Trial name
- NCT01256294
- Testing
- Generic Tacrolimus, Branded Tacrolimus
- Where
- 2 sites in United States
- Volunteers
- 71 people
- Sponsor
- Novartis
Liver Transplantation
Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate…
- Trial name
- RAD (NCT00622869)
- Testing
- Tacrolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination), Tacrolimus (tacrolimus control)
- Where
- 91 sites in United States, Argentina and 17 more
- Volunteers
- 719 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and…
- Trial name
- NCT00106639
- Testing
- CP-690,550, tacrolimus
- Where
- 20 sites in United States
- Volunteers
- 61 people
- Sponsor
- Pfizer
Kidney Failure, Renal Failure
Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients
The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by…
- Trial name
- NCT00765661
- Testing
- Tacrolimus (Tacro™), Prograf
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Veloxis Pharmaceuticals
Liver Transplantation
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282256
- Testing
- tacrolimus modified release (MR), tacrolimus
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- Astellas Pharma Inc
Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft
Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate Sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate Mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.
Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.
- Trial name
- MAXIMIZA (NCT01056822)
- Testing
- 1, 2
- Where
- 19 sites in Spain
- Volunteers
- 89 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplant Recipient
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients.
- Trial name
- NCT01150097
- Testing
- Tacrolimus (reduced tacrolimus), Everolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination)
- Where
- 57 sites in United States, Argentina and 14 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282243
- Testing
- tacrolimus modified release (MR), tacrolimus
- Where
- 10 sites in United States
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
- Trial name
- NCT01888432
- Testing
- Everolimus + reduced tacrolimus, Standard tacrolimus
- Where
- 42 sites in United States, Canada and 11 more
- Volunteers
- 285 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection.
- Trial name
- NCT00263328
- Testing
- Tacrolimus, CP-690,550
- Where
- 27 sites in United States
- Volunteers
- 46 people
- Sponsor
- Pfizer
Chronic Renal Failure
Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients
The primary objective of this trial is to show non-inferiority of a CNI-free regimen with respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard…
- Trial name
- NCT00965094
- Testing
- Everolimus, Tacrolimus (FK506), Basiliximab
- Where
- 3 sites in Israel
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Heart Diseases, Heart Transplantation
Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
- Trial name
- NCT00157014
- Testing
- Tacrolimus, Cyclosporine, Mycophenolate mofetil
- Where
- 13 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants.
- Trial name
- NCT00758602
- Testing
- mycophenolate mofetil, tacrolimus, standard dose, tacrolimus, low dose
- Where
- 6 sites in China
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
Liver Transplant
Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients
The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored…
- Trial name
- NCT00149994
- Testing
- Cyclosporine A, Tacrolimus, Basiliximab
- Where
- Switzerland
- Volunteers
- 171 people
- Sponsor
- Novartis Pharmaceuticals
Renal Failure
Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
- Trial name
- NCT01666951
- Testing
- LCP-Tacro tablets, Prograf
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- Veloxis Pharmaceuticals
Liver Transplant, Hepatitis C
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver.
- Trial name
- NCT00260208
- Testing
- Cyclosporine A, Tacrolimus
- Where
- 2 sites in United States, Switzerland
- Volunteers
- 361 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282568
- Testing
- Tacrolimus Modified Release (MR), tacrolimus
- Where
- 9 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Inc
Kidney Diseases
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to…
- Trial name
- OLYMPE (NCT00284934)
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus, Corticosteroids
- Where
- Switzerland
- Volunteers
- 94 people
- Sponsor
- Novartis
Liver Transplantation
REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy
The purpose of this study was, starting from the Italian clinical practice in liver transplantation, to optimize the immunosuppressive therapy, considering specific patient characteristics as alcoholic cirrhosis, hepatitis C…
- Trial name
- REFLECT (NCT02115113)
- Testing
- Everolimus, Tacrolimus
- Where
- 14 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation, Renal Transplantation
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in…
- Trial name
- ATHENA (NCT01843348)
- Testing
- Everolimus, Tacrolimus, Cyclosporin A
- Where
- 27 sites in France, Germany
- Volunteers
- 612 people
- Sponsor
- Novartis Pharmaceuticals