Clinical trials: Tacrolimus
Kidney Transplantation
Optima: Optimizing Prograf Therapy in Maintenance Allografts II
This study is designed to optimize calcineurin immunosuppressive regimens and evaluate immunological and non-immunological markers that may explain mechanistic differences in these agents and their effects.
- Trial name
- OPTIMAII (NCT00905515)
- Testing
- cyclosporine, Prograf (Tacrolimus)
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- East Carolina University
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
Immunosuppression, Renal Failure
Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
This study will examine the renal sparing impact of implementing a strategy of conversion to everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post liver transplant
- Trial name
- NCT01936519
- Testing
- Arm A: Everolimus, Calcineurin Inhibitor
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Milton S. Hershey Medical Center
Chronic Myeloproliferative Disorders, Leukemia
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Trial name
- NCT00691015
- Testing
- rituximab, busulfan, carmustine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
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
Hypertension
Pharmacokinetics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Tacrolimus Toxicity
Pharmacokinetics of Tacrolimus and Sirolimus alone and in combination in liver transplant recipients.
- Trial name
- Sirolimus (NCT01709136)
- Testing
- Sirolimus
- Volunteers
- 3 people
- Sponsor
- University of Pittsburgh
Kidney Transplant
Renal Allograft Function and Histology Following Switching From A Tacrolimus to Sirolimus (SRL)-Based Immunosuppression-
The investigators hypothesize that Tacrolimus (Tac) withdrawal from a Tac, MMF and steroid based triple therapy regimen leads to long term improved/stabilized graft function (glomerular filtration rate, GFR) primarily as a…
- Trial name
- NCT01166724
- Testing
- Sirolimus, Tacrolimus
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- The Cleveland Clinic
Renal Transplant Rejection, Transplants and Implants
Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients
To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.
- Trial name
- NCT00771745
- Testing
- Thymoglobulin
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Cincinnati
Renal Transplant Recipients
Research Study of ATG and Rituximab in Renal Transplantation
The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given at the time of the transplant surgery, will help reduce or eliminate the need for long term immunosuppressive medication.
- Trial name
- RESTARRT (NCT01318915)
- Testing
- ATG, Rituximab, Tacrolimus
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Study of Sirolimus Versus Mycophenolate Liver Transplant Recipients With Recurrent Hepatitis C Virus (HCV)
Different immunosuppressive drugs used in transplantation may reduce the body's defences against infection differently. It is known that patients with Hepatitis C virus, known as HCV, who switched from azathioprine to…
- Trial name
- NCT01134952
- Testing
- Mycophenolate to sirolimus switch
- Where
- Canada
- Volunteers
- 11 people
- Sponsor
- London Health Sciences Centre
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
Transplants and Implants
Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant
The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while…
- Trial name
- NCT00596947
- Testing
- prednisone, rabbit antithymocyte globulin, Tacrolimus
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Pennsylvania
Immunosuppression
Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status
Tacrolimus (Prograf) is a medication that is commonly used in patients who receive a kidney transplant. It is considered to be one of the most important medications that prevent rejection of the transplant kidney by suppressing…
- Trial name
- TIMELY (NCT00731874)
- Testing
- Tacrolimus
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Weill Medical College of Cornell University
Chronic Myeloproliferative Disorders, Graft Versus Host Disease
Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation
This Phase II clinical trial was designed for patients with hematologic malignancies in need of donor peripheral blood stem cell transplant, and have no HLA matched donor.
- Conditions
- Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma
- Trial name
- NCT01116232
- Testing
- anti-thymocyte globulin, rituximab, sirolimus
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
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
Kidney Transplant
Dosing Strategies for de Novo Once-daily Extended Release Tacrolimus (LCPT) in Kidney Transplant Recipients
Outcomes after kidney transplantation have been significantly enhanced with the advances made in immunosuppressive therapies. Tacrolimus is currently marketed as an extended-release once-daily formulation dosing option for…
- Trial name
- NCT03713645
- Testing
- Tacrolimus Extended Release Oral Tablet [Envarsus] 0.13mg/kg/day initiated within post-operative day 3 after kidney transplant
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Temple University
Kidney Transplant, Diabetes Mellitus, Type 2
Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)
Protocol Title: Randomized open label study comparing the metabolic control of first Kidney Transplant recipients with Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral as part of a ATG induction, prednisone free…
- Conditions
- Kidney Transplant, Diabetes Mellitus, Type 2, Diabetic Nephropathy
- Trial name
- NCT00296296
- Testing
- Cyclosporin, Tacrolimus, 'Diabetes Education / Management'
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Stanford University
Lymphoma, Leukemia
Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies
Primary Objective: 1. To determine whether the primary endpoint: the composite success rate, defined as the proportion of patients who are alive at day 100; and are without grade 3-4 Graft versus Host Disease (GVHD); and are…
- Trial name
- NCT00476229
- Testing
- Thymoglobulin, Total Lymphoid Irradiation, Peripheral Blood Stem Cell Infusion
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- M.D. Anderson Cancer Center