Clinical trials: Tacrolimus
Hematopoietic Stem Cell Transplantation
A Study of Tacrolimus/Methotrexate and Tocilizumab to Prevent Acute Graft-Versus-Host Disease (AGVD) After Allogeneic Hematopoietic Stem Cell Transplant
This is a phase II open label trial designed to evaluate the efficacy of Tac/MTX/Toc in preventing graft versus host disease (GVHD).
- Trial name
- NCT02206035
- Testing
- Tacrolimus, Methotrexate, Tocilizumab
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- William R. Drobyski, MD
End Stage Renal Disease (ESRD)
Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
- Trial name
- NCT00374803
- Testing
- Mycophenolic Acid (Myfortic)
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- University of Cincinnati
Liver Transplantation
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g.
- Trial name
- NCT02736227
- Testing
- Tacrolimus Withdrawal and Everolimus Monotherapy
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Northwestern University
Liver Transplantation
Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant
This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called…
- Trial name
- NCT00970073
- Testing
- Thymoglobulin 3mg total, Thymoglobulin 4.5mg total, Mycophenolate mofetil
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The Cleveland Clinic
Renal Transplant Infection
Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection
The purpose of this study is to assess if the use of Envarsus in place of Tacrolimus-immediate release (IR) in rapid metabolizers post kidney transplant will reduce incidence of BK infection.
- Trial name
- NCT03762473
- Testing
- Study Group, Control Group
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- University of Alabama at Birmingham
Desmoplastic Small Round Cell Tumor, Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Donor Stem Cell Transplant After Chemotherapy for the Treatment of Recurrent or Refractory High-Risk Solid Tumors in Pediatric and Adolescent-Young Adults
This phase II trial investigates side effects and how well donor stem cell transplant after chemotherapy works in treating pediatric and adolescent-young adults with high-risk solid tumor that has come back (recurrent) or does…
- Conditions
- Desmoplastic Small Round Cell Tumor, Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Desmoplastic Small Round Cell Tumor, Recurrent Malignant Peripheral Nerve Sheath Tumor
- Trial name
- NCT04530487
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Cyclosporine, Etoposide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- M.D. Anderson Cancer Center
Liver Transplantation
Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for…
- Trial name
- NCT00374231
- Testing
- tacrolimus, mycophenolate mofetil, Prednisone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Cincinnati
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
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer
This phase I/II trial studies the side effects and best dose of donor natural killer (NK) cell therapy and to see how well it works when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation, donor…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aggressive Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma
- Trial name
- NCT00789776
- Testing
- Allogeneic Bone Marrow Transplantation, Cyclophosphamide, Fludarabine Phosphate
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- Fred Hutchinson Cancer Center
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)
Crohn Disease
Crohn's Allogeneic Transplant Study
This phase II trial studies how well giving a donor bone marrow transplant (BMT) works in treating patients with refractory Crohn's Disease.
- Trial name
- CATS (NCT01570348)
- Testing
- Allogeneic Bone Marrow Transplantation, Cyclophosphamide, Fludarabine Phosphate
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Fred Hutchinson Cancer Center
Sarcoma, Malignant Peripheral Nerve Sheath Tumors
PLX3397 Plus Sirolimus in Unresectable Sarcoma and Malignant Peripheral Nerve Sheath Tumors
The purpose of this study is to determine if treatment with PLX3397 and Sirolimus will be tolerated and result in shrinking of the cancer or stopping the cancer from growing.
- Trial name
- PLX3397 (NCT02584647)
- Testing
- PLX3397, sirolimus
- Where
- 5 sites in United States
- Volunteers
- 39 people
- Sponsor
- Gulam Manji
Transplant; Failure, Kidney, EBV
Belatacept 3 Month Post Transplant Conversion Study
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation.
- Trial name
- NCT02213068
- Testing
- belatacept, Tacrolimus, MPA
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Lorenzo Gallon
Skin Cancer
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on the dosage (i.e.…
- Trial name
- PROSKIN (NCT00866684)
- Testing
- Sirolimus, Azathioprine, Mycophenolate
- Where
- 15 sites in Germany
- Volunteers
- 44 people
- Sponsor
- Charite University, Berlin, Germany
Kidney Transplant, Delayed Graft Function
Tacrolimus to Sirolimus Conversion for Delayed Graft Function
The objective of this study is to evaluate the safety and efficacy of conversion from tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft function (DGF)and slow graft function (SGF) in…
- Trial name
- RAPA (NCT00931255)
- Testing
- Tacrolimus, Sirolimus
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- University of Maryland, Baltimore
Kidney Transplant; Complications
Once Daily Immunosuppression Regimen
The purpose of this research study is to determine whether an immunosuppressive maintenance regimen of Envarsus/azathioprine compared to a tacrolimus/ mycophenolic acid regimen is associated with better compliance, tolerability…
- Trial name
- NCT03555448
- Testing
- Once daily immunosuppression regimen, Twice daily immunosuppression regimen
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Washington University School of Medicine
Liver Transplantation
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
- Trial name
- NCT01888432
- Testing
- Everolimus + reduced tacrolimus, Standard tacrolimus
- Where
- 42 sites in United States, Canada and 11 more
- Volunteers
- 285 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
Kidney Transplantation, Chronic Kidney Failure
Early Conversion From Tacrolimus to Efalizumab Maintenance Therapy in Kidney Transplant Recipients
The toxicity of calcineurin inhibitors(CNI)is a major factor limiting the success of renal transplantation. This protocol aims to replace the calcineurin inhibitor, tacrolimus, with efalizumab early after transplantation in…
- Trial name
- NCT00472082
- Testing
- efalizumab
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Emory University
Acute Leukemia, Myelodysplasia
Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301)
The study is designed as a three arm randomized Phase III, multicenter trial comparing two calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis to standard tacrolimus and methotrexate…
- Trial name
- NCT02345850
- Testing
- Unmanipulated Bone Marrow Graft with Tacrolimus/Methotrexate, Mobilized CD34-selected Peripheral Blood Stem Cell graft, Unmanipulated Bone Marrow Graft with Cyclophosphamide
- Where
- 28 sites in United States
- Volunteers
- 346 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)