Clinical trials: Tacrolimus
Renal Transplant Failure and Rejection
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
The goal of this clinical trial is to learn if siplizumab can prevent rejection of a kidney transplant in adult participants with end stage kidney disease.
- Trial name
- MODERNIZE1 (NCT07508787)
- Testing
- Siplizumab, Rabbit anti-thymocyte globulin
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 120 people
- Sponsor
- Nefro Avillion Clinical Development, LLC
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
Myasthenia Gravis
FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.
- Trial name
- NCT00309088
- Testing
- tacrolimus
- Where
- 9 sites in Japan
- Volunteers
- 80 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation, Liver Transplantation
A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients
The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using…
- Trial name
- MITRA (NCT03465969)
- Testing
- tacrolimus
- Where
- 4 sites in France, United Kingdom
- Volunteers
- 80 people
- Sponsor
- Astellas Pharma Europe Ltd.
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
Kidney Transplantation
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients
To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients
- Trial name
- NCT00720265
- Testing
- Prograf, MR4
- Where
- 2 sites in South Korea
- Volunteers
- 135 people
- Sponsor
- Astellas Pharma Inc
Heart Transplantation, Lung Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery.
- Conditions
- Heart Transplantation, Lung Transplantation, Pancreas (Including SPK) Transplantation
- Trial name
- NCT01332201
- Testing
- Advagraf, Prograf
- Where
- 8 sites in Austria, Belgium and 4 more
- Volunteers
- 17 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.
A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate…
- Trial name
- Prometheus (NCT03596970)
- Testing
- TAC withdrawal, Everolimus with reduced TAC
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community Clinics
This is a multicentre, observational, non-interventional, retrospective analysis by chart review.
- Trial name
- NCT00902980
- Testing
- Chart Review
- Where
- 13 sites in Canada
- Volunteers
- 264 people
- Sponsor
- Astellas Pharma Inc
Healthy
A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults
This was a 3-part study with each part being an open-label, fixed-sequence, 2-period study in healthy adult participants.
- Trial name
- NCT05109390
- Testing
- Danicopan, Cyclosporine, Tacrolimus
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Dermatitis, Atopic
Protopic Ointment in Adult Atopic Eczema of the Face
Patients with facial atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks.
- Trial name
- NCT00690105
- Testing
- tacrolimus 0.1%, fluticasone 0.005 %
- Where
- France
- Volunteers
- 577 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
Hepatitis C Virus
A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 (administered once a day) on the single-dose pharmacokinetics of the immunosuppressants cyclosporine and tacrolimus in healthy…
- Trial name
- NCT01479881
- Testing
- tacrolimus, TMC435, cyclosporine
- Where
- Belgium
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Kidney Transplant Rejection
Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.
- Trial name
- LEGACY (NCT07835581)
- Testing
- Tegoprubart, Tacrolimus
- Volunteers
- 620 people
- Sponsor
- Eledon Pharmaceuticals
Healthy Volunteers
Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fed 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
- NCT01080469
- Testing
- Tacrolimus 1 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
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
Kidney Transplantation, Liver Transplantation
A Study to Demonstrate Safety and Efficacy of Advagraf in Patients Undergoing Kidney or Liver Transplantation in India
The objective of the study is to demonstrate safety and efficacy of once-daily Advagraf in adult population undergoing kidney or liver transplantation in India.
- Trial name
- NCT02432053
- Testing
- Advagraf
- Where
- 7 sites in India
- Volunteers
- 92 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
Ulcerative Colitis
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in…
- Trial name
- NCT00347048
- Testing
- tacrolimus
- Where
- 6 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Astellas Pharma Inc
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