Clinical trials: Tacrolimus
Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
- Trial name
- NCT00282230
- Testing
- FK778
- Where
- 23 sites in United States
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related…
- Trial name
- NCT00267189
- Testing
- Everolimus, Calcineurin inhibitors (CNI), Mycophenolate acid (MPA)/ Azathioprine (AZA)
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 145 people
- Sponsor
- Novartis Pharmaceuticals
Moderate/Severe Atopic Dermatitis
Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.
- Trial name
- NCT01745159
- Testing
- tacrolimus
- Where
- 4 sites in China
- Volunteers
- 125 people
- Sponsor
- Astellas Pharma China, Inc.
Kidney Transplantation, Primary Focal Segmental Glomerulosclerosis (FSGS)
Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
The purpose of this study was to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus…
- Trial name
- NCT02921789
- Testing
- Bleselumab, Basiliximab, Mycophenolate Mofetil (MMF)
- Where
- 23 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Graft Rejection, Kidney Transplant
Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.
- Conditions
- Graft Rejection, Kidney Transplant, Renal Allograft Recipients, Renal Transplant
- Trial name
- NCT00895583
- Testing
- Tacrolimus, Sirolimus
- Where
- 44 sites in United States, Argentina and 5 more
- Volunteers
- 254 people
- Sponsor
- Pfizer
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation, Heart Transplantation
A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics).
- Conditions
- Kidney Transplantation, Heart Transplantation, Liver Transplantation
- Trial name
- OPTION (NCT01371331)
- Testing
- Tacrolimus granules
- Where
- 10 sites in Belgium, France and 4 more
- Volunteers
- 52 people
- Sponsor
- Astellas Pharma Europe Ltd.
Age-Related Macular Degeneration
Study to Evaluate Sub-retinal Transplantation of Retinal Pigmented Epithelial Cells in Patients With Dry AMD
To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection prophylaxis prior to and/or following transplant of MA09-hRPE cells.
- Trial name
- PORTRAY (NCT02563782)
- Testing
- Sub-retinal transplantation of MA09-hRPE cells, tacrolimus and mycophenolate mofetil
- Where
- United States
- Sponsor
- Astellas Institute for Regenerative Medicine
Kidney Transplantation, Transplantation
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
The purpose of this study is to evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after transplantation.
- Trial name
- NCT00297310
- Testing
- tacrolimus
- Volunteers
- 89 people
- Sponsor
- Janssen-Cilag Pty Ltd
Type 1 Diabetes Mellitus
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the safety of islet preparation, iset transplantation…
- Trial name
- NCT00679042
- Testing
- Islets of Langerhans transplantation
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- CellTrans Inc.
KIDNEY TRANSPLANTATION
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids versus tacrolimus plus MMF, following induction with…
- Trial name
- TIGRE (NCT00321113)
- Testing
- tacrolimus, mycophenolate mofetil, steroids
- Where
- 14 sites in Italy
- Volunteers
- 142 people
- Sponsor
- Astellas Pharma Inc
Acute Leukemia, Acute Lymphoblastic Leukemia
A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain…
- Conditions
- Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Biphenotypic Leukemia
- Trial name
- NCT05589896
- Testing
- Ossium HPC Marrow, Bone Marrow Transplant, Pre-transplant conditioning - Myeloablative (MAC), Pre-transplant conditioning - Reduced Intensity (RIC)
- Where
- 9 sites in United States
- Volunteers
- 12 people
- Sponsor
- Ossium Health, Inc.
Liver Transplant, Kidney Transplant
A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients.
- Trial name
- ADDRESS (NCT02057484)
- Testing
- Tacrolimus
- Where
- 145 sites in Austria, Belarus and 22 more
- Volunteers
- 2,300 people
- Sponsor
- Astellas Pharma Europe Ltd.
Rheumatoid Arthritis
Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients
This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and biological agents.
- Trial name
- NCT01870908
- Testing
- tacrolimus, biological agents
- Where
- 7 sites in Japan
- Volunteers
- 664 people
- Sponsor
- Astellas Pharma Inc
Renal Transplantation
Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation
The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.
- Trial name
- INSPIRE (NCT01586845)
- Testing
- voclosporin, tacrolimus
- Sponsor
- Aurinia Pharmaceuticals 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
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.
Liver Transplantation
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients
To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation.
- Trial name
- NCT00719745
- Testing
- Prograf, MR4
- Where
- South Korea
- Volunteers
- 74 people
- Sponsor
- Astellas Pharma Inc
DiGeorge Anomaly, Complete DiGeorge Anomaly
Phase I/II Thymus Transplantation With Immunosuppression #950
The study purpose is to determine if cultured thymus tissue implantation (CTTI) (previously described as transplantation) with tailored immunosuppression based on the recipient's pre-implantation T cell population is a safe and…
- Conditions
- DiGeorge Anomaly, Complete DiGeorge Anomaly, Complete Atypical DiGeorge Anomaly, Complete DiGeorge Syndrome
- Trial name
- #950 (NCT00579527)
- Testing
- Cultured Thymus Tissue for Implantation (CTTI), Cultured Thymus Tissue Implantation and Parental Parathyroid Transplantation, Blood Draw
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
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