Clinical trials: Tacrolimus, completed
Liver Transplantation
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.
- Trial name
- NCT00909571
- Testing
- FK506E (modified release tacrolimus), Prograf (tacrolimus)
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Astellas Pharma Inc
Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)
The objective of this trial was to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in double lung transplant (DLT) recipients…
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications
- Trial name
- BOSTON-2 (NCT03656926)
- Testing
- Liposomal Cyclosporine A, Standard of Care
- Where
- 40 sites in United States, Austria and 7 more
- Volunteers
- 169 people
- Sponsor
- Zambon SpA
Atopic Dermatitis
Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Atopic Dermatitis
The primary objectives are to establish the therapeutic equivalence of tacrolimus ointment 0.1%, manufactured by Taro Pharmaceuticals Inc.
- Trial name
- NCT00833079
- Testing
- Tacrolimus 0.1% manufactured by Taro, Protopic - Tacrolimus 0.1%, Tacrolimus Vehicle manufactured by Taro
- Volunteers
- 500 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Disorder Related to Renal Transplantation
A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation
The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar…
- Trial name
- NCT00455013
- Testing
- Thymoglobulin, Belatacept, Sirolimus
- Where
- 17 sites in United States, Italy and 1 more
- Volunteers
- 93 people
- Sponsor
- Bristol-Myers Squibb
the Maintenance Phase After Kidney Transplantation
Specified Drug Use-results Survey of Graceptor in Patients With Kidney Transplantation (Switching From Cyclosporine)
To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine
- Trial name
- NCT02160054
- Testing
- Graceptor®
- Where
- 30 sites in Japan
- Volunteers
- 289 people
- Sponsor
- Astellas Pharma Inc
Dermatitis
Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis
A study of subjects with a known nickel allergy comparing Tacrolimus to placebo, both associated with nickel patches to determine the safety and efficacy of treating Chronic Allergic Contact Dermatitis with Tacrolimus Ointment
- Trial name
- NCT00667056
- Testing
- tacrolimus ointment
- Where
- 10 sites in United States
- Volunteers
- 98 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation
Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®.
- Trial name
- OPTIMIZE (NCT02161237)
- Testing
- Advagraf®
- Where
- 2 sites in South Korea, Taiwan
- Volunteers
- 73 people
- Sponsor
- Astellas Pharma Inc
Dermatitis, Atopic
A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis
A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis
- Trial name
- NCT00666302
- Testing
- tacrolimus ointment, pimecrolimus cream
- Where
- 15 sites in United States, Canada
- Volunteers
- 413 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients
This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recipients.
- Trial name
- Assign (NCT04761731)
- Testing
- ADVAGRAF®
- Volunteers
- 31 people
- Sponsor
- Linical Korea
Dry Eye Disease (DED)
Safety and Efficacy Study of RTP-008 (an Absorbable Tacrolimus Lacrimal Canalicular Plug) for Dry Eye
RTP-008, an absorbable tacrolimus lacrimal canalicular plug, targets two key pathophysiological mechanisms of dry eye: tear retention and local anti-inflammation.
- Trial name
- NCT07806240
- Testing
- RTP-008, Dissolvable Plug
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Zhejiang Raytone Bioscience Co.,Ltd
Ulcerative Colitis
Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients
Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.
- Trial name
- NCT00643071
- Testing
- Tacrolimus
- Where
- 6 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Astellas Pharma Inc
Lupus Nephritis
A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations
To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.
- Trial name
- TRUST (NCT01410747)
- Testing
- Tacrolimus
- Where
- 8 sites in Japan
- Volunteers
- 1,484 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic…
- Trial name
- NCT00337493
- Testing
- mycophenolate mofetil [CellCept], Cyclosporine or tacrolimus
- Where
- 20 sites in United States
- Volunteers
- 155 people
- Sponsor
- Hoffmann-La Roche
Dermatitis, Atopic
Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis
The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.
- Trial name
- NCT00560326
- Testing
- Tacrolimus Ointment 0.03%
- Where
- 8 sites in Canada, Finland and 3 more
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc
Healthy Volunteers
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fed Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080534
- Testing
- Tacrolimus 5 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Kidney Transplantation
A Dose Escalation Study in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT04311632
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- ITB-Med LLC
Kidney Transplantation
Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts
This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.
- Trial name
- NCT00933231
- Testing
- tacrolimus, Simulect, Cellcept
- Where
- 13 sites in Canada
- Volunteers
- 281 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.
- Trial name
- HEPHAISTOS (NCT01551212)
- Testing
- Everolimus, Tacrolimus, Corticosteroids
- Where
- 15 sites in Germany
- Volunteers
- 339 people
- Sponsor
- Novartis Pharmaceuticals
Transplantation
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive…
- Trial name
- NCT00384137
- Testing
- Tacrolimus
- Where
- 13 sites in France, Germany and 4 more
- Volunteers
- 128 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation
Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped.
- Trial name
- DISTAMP (NCT00693381)
- Testing
- Tacrolimus, Mycophenolate Mofetil, methylprednisolone and prednisone
- Where
- 14 sites in Czechia, Hungary and 2 more
- Volunteers
- 152 people
- Sponsor
- Astellas Pharma Inc