Clinical trials: Tacrolimus
Kidney Transplantation
Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients
The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a…
- Trial name
- NCT00519116
- Testing
- Rapamune® (Sirolimus), Tacrolimus, Perioperative Corticosteroids
- Volunteers
- 150 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Kidney Transplant
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients
The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus (TacroBell SR Cap.) in patients who received renal transplantation.
- Trial name
- OPIRUS (NCT03749356)
- Testing
- TacroBell SR cap.
- Where
- South Korea
- Volunteers
- 141 people
- Sponsor
- Chong Kun Dang Pharmaceutical
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
Pharmacokinetics of ASP015K, Drug Interactions
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Tacrolimus in Healthy Volunteers
This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.
- Conditions
- Pharmacokinetics of ASP015K, Drug Interactions, Healthy Subjects
- Trial name
- NCT01430065
- Testing
- ASP015K, Tacrolimus
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients
This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients.
- Trial name
- NCT00619398
- Testing
- Prograf, FK506MR capsule
- Where
- 6 sites in China
- Volunteers
- 172 people
- Sponsor
- Astellas Pharma Inc
Keratoconjunctivitis, Conjunctivitis
Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis
- Trial name
- NCT00567762
- Testing
- FK506
- Where
- 8 sites in Japan
- Volunteers
- 56 people
- Sponsor
- Astellas Pharma Inc
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
Graft-versus-host Disease (GVHD)
A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood…
- Trial name
- NCT06615050
- Testing
- Tacrolimus (Tac), Methotrexate (MTX), Ruxolitinib (Rux)
- Where
- 30 sites in United States
- Volunteers
- 572 people
- Sponsor
- Incyte Corporation
Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation
The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in…
- Trial name
- NCT00189839
- Testing
- tacrolimus
- Where
- 80 sites in Argentina, Australia and 21 more
- Volunteers
- 699 people
- Sponsor
- Astellas Pharma Inc
Healthy Volunteers
Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fasting Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080456
- Testing
- Tacrolimus 1 mg capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Psoriasis
A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis
A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis
- Trial name
- NCT00293930
- Testing
- Tacrolimus
- Where
- 32 sites in United States, Canada
- Volunteers
- 645 people
- Sponsor
- Astellas Pharma Inc
Asthma
A Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma
The purpose of this study is to determine the safety and effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma.
- Trial name
- NCT00116103
- Testing
- Tacrolimus Inhalation Aerosol
- Where
- 21 sites in United States
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection…
- Trial name
- NCT00885820
- Testing
- Tacrolimus, MMF, Corticosteroids (Prednisone)
- Where
- 12 sites in United States, Canada
- Volunteers
- 240 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.
- Trial name
- NCT01128335
- Testing
- MMF(1000mg bid) + tacrolimus + standard of care medications, sotrastaurin (200mg bid) + tacrolimus + standard of care medications, sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
- Where
- 39 sites in United States, Argentina and 10 more
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH)
A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations
This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized…
- Conditions
- Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Pulmonary Arterial Hypertension PAH
- Trial name
- TRANSCEND (NCT07612657)
- Testing
- VI-0106
- Volunteers
- 300 people
- Sponsor
- VIVUS LLC
Healthy
Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants
This study will evaluate the potential drug interactions between ALXN2050 and cyclosporine (Part 1), between ALXN2050 and tacrolimus (Part 2), and between ALXN2050 and mycophenolate mofetil (MMF) (Part 3).
- Trial name
- NCT05202145
- Testing
- ALXN2050, Cyclosporine, Tacrolimus
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Dermatitis, Atopic, Eczema, Atopic
Long-term Safety of Protopic in Atopic Eczema
Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%
- Trial name
- NCT00560378
- Testing
- Tacrolimus ointment 0.1%
- Where
- 41 sites in Belgium, Denmark and 10 more
- Volunteers
- 789 people
- Sponsor
- Astellas Pharma Inc
Healthy Male Volunteers
The Study of Pharmacokinetic Interactions Between HL237 and Tacrolimus
This study aims to evaluate the pharmacokinetic interaction between HL237 and tacrolimus in healthy male subjects.
- Trial name
- NCT04633733
- Testing
- HL237 tablet, tacrolimus capsule
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Hanlim Pharm. Co., Ltd.