Clinical trials: Tacrolimus
- Drug or intervention Tacrolimus
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
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
Hematopoietic Stem Cell Transplantation, Acute Graft Versus Host Disease
Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)
The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate.
- Conditions
- Hematopoietic Stem Cell Transplantation, Acute Graft Versus Host Disease, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
- Trial name
- CATHY (NCT04095858)
- Testing
- Efprezimod alfa, Methotrexate, Tacrolimus
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Kidney Transplant
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.
- Trial name
- NCT01025817
- Testing
- Everolimus and tacrolimus, mycophenolate mofetil and tacrolimus
- Where
- 50 sites in United States, Canada
- Volunteers
- 613 people
- Sponsor
- Novartis Pharmaceuticals
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
Renal Failure, Tremors
Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
This study will evaluate and measure symptomatic hand tremor in stable kidney transplant subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion) and following conversion to LCP-Tacro.
- Trial name
- STRATO (NCT01438710)
- Testing
- Prograf, LCP-Tacro
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Veloxis Pharmaceuticals
Liver Failure
Pharmacokinetics of LCP-Tacro in Stable Liver Transplant Patients
A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf…
- Trial name
- NCT00608244
- Testing
- LCP Tacro, Prograf
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Veloxis Pharmaceuticals
Liver Transplantation
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant.
- Trial name
- NCT00118742
- Testing
- mycophenolate mofetil [CellCept], Tacrolimus, Cyclosporine
- Where
- 46 sites in United States, Canada
- Volunteers
- 293 people
- Sponsor
- Hoffmann-La Roche
Liver Transplant
A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC…
- Trial name
- REDUCE (NCT02040584)
- Testing
- Minimisation of TAC, TAC + MMF + corticosteroids
- Where
- 20 sites in Spain
- Volunteers
- 217 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C, Chronic
A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation
The purpose of the study is to evaluate effect of steady-state (when the amount of drug administered (in a given time period is equal to the amount of drug eliminated in that same period) of simeprevir and daclatasvir on the…
- Trial name
- NCT01938625
- Testing
- Simeprevir, Daclatasvir, Ribavirin
- Where
- 6 sites in Germany, Poland and 1 more
- Volunteers
- 35 people
- Sponsor
- Janssen R&D Ireland
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
Disorder Related to Cardiac Transplantation
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.
- Trial name
- NOCTET (NCT00377962)
- Testing
- Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA), Calcineurin inhibitors (CNI)
- Where
- 6 sites in Denmark, Norway and 1 more
- Volunteers
- 282 people
- Sponsor
- Novartis Pharmaceuticals
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.
Liver Transplantation
A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients
The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to…
- Trial name
- SIMCER (NCT01625377)
- Testing
- tacrolimus, everolimus, Basiliximab
- Where
- 14 sites in France
- Volunteers
- 188 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
- Trial name
- NCT00086346
- Testing
- Sirolimus (Rapamune), Cyclosporine or Tacrolimus
- Where
- 42 sites in United States, Belgium and 10 more
- Volunteers
- 607 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Pancreatic Islet Transplantation in Type 1 Diabetes Mellitus
Reparixin in Pancreatic Islet Transplantation
Inhibition of CXCL8 activity might represent a relevant therapeutic target to prevent injury occurring after pancreatic islet transplantation. Reparixin is a novel and specific inhibitor of CXCL8.
- Trial name
- NCT01220856
- Testing
- Reparixin
- Where
- 2 sites in Germany, Italy
- Volunteers
- 9 people
- Sponsor
- Dompé Farmaceutici S.p.A
Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
The objective of this trial is 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 single lung transplant recipients with…
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications
- Trial name
- BOSTON-1 (NCT03657342)
- Testing
- Liposomal Cyclosporine A, standard of care
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 62 people
- Sponsor
- Zambon SpA
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
Kidney Transplantation
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
- Trial name
- CIRRUS I (NCT03663335)
- Testing
- CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), Corticosteroids (CS)
- Where
- 74 sites in United States, Argentina and 18 more
- Volunteers
- 418 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Undifferentiated Leukemia
- Trial name
- Orca-T (NCT05316701)
- Testing
- Orca-T, Standard-of-Care
- Where
- 19 sites in United States
- Volunteers
- 187 people
- Sponsor
- Orca Biosystems, Inc.
Renal Transplant
A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant.
- Trial name
- NCT00402168
- Testing
- Belatacept, Cyclosporine A, Tacrolimus
- Where
- 44 sites in United States, Argentina and 10 more
- Volunteers
- 173 people
- Sponsor
- Bristol-Myers Squibb