Clinical trials: Tacrolimus
Heart Transplantation, Liver Transplantation
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus through genetics will help in early attainment and…
- Conditions
- Heart Transplantation, Liver Transplantation, Kidney Transplantation
- Trial name
- NCT01655563
- Testing
- Tacrolimus
- Where
- Canada
- Volunteers
- 75 people
- Sponsor
- The Hospital for Sick Children
Renal Transplant Rejection
A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity
This study aims to compare outcomes in renal transplant recipients in the hispanic population based on their immunosuppressant regimens.
- Trial name
- NCT00983645
- Testing
- Prograf, Neoral
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Loma Linda University
Kidney Diseases, Kidney Transplantation
Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation
Over the last 40 years, corticosteroids (steroids) have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ transplants.
- Conditions
- Kidney Diseases, Kidney Transplantation, Kidney Transplant, Renal Transplantation
- Trial name
- NCT00141037
- Testing
- Daclizumab, Mycophenolate mofetil (MMF), Prednisone
- Where
- 12 sites in United States
- Volunteers
- 130 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant; Complications, Toxicity
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related…
- Conditions
- Kidney Transplant; Complications, Toxicity, Drug Toxicity, Neurotoxicity
- Trial name
- NCT03461445
- Testing
- Envarsus, IR Tacrolimus
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- University of California, Davis
Kidney Transplant Infection
Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation
This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus.
- Trial name
- SEM (NCT03468478)
- Testing
- Sirolimus, Everolimus, Mycophenolic acid
- Where
- Brazil
- Volunteers
- 1,209 people
- Sponsor
- Hospital do Rim e Hipertensão
Kidney Transplantation, Renal Transplantation
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in…
- Trial name
- ATHENA (NCT01843348)
- Testing
- Everolimus, Tacrolimus, Cyclosporin A
- Where
- 27 sites in France, Germany
- Volunteers
- 612 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation
This is an investigator initiated study at the University of California, Los Angeles (UCLA) funded by Novartis looking at using a combination of immunosuppressive drugs in liver transplant patients that are at risk of developing…
- Trial name
- NCT02123108
- Testing
- Basiliximab, Tacrolimus, Mycophenolic Acid
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- University of California, Los Angeles
Transplantation
Functional Genetic Variants Affecting Tacrolimus Trough Levels and Side Effects in Chinese Renal Transplantation.
The purpose of this study is to determine whether functional genetic variants can affect tacrolimus dose corrected trough levels and associate with the side effects in Chinese renal transplant recipients.
- Trial name
- NCT03083769
- Where
- 2 sites in China
- Volunteers
- 1,502 people
- Sponsor
- Southern Medical University, China
Chronic Renal Failure
Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients
The primary objective of this trial is to show non-inferiority of a CNI-free regimen with respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard…
- Trial name
- NCT00965094
- Testing
- Everolimus, Tacrolimus (FK506), Basiliximab
- Where
- 3 sites in Israel
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplant Rejection
Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant.
- Trial name
- NCT00866879
- Testing
- Sirolimus, Demographic Data, Medical History, and Donor Data, Blood Draws for Control Group
- Where
- United States
- Volunteers
- 275 people
- Sponsor
- Northwestern University
Evidence of Liver Transplantation, Rejection
Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation
This open-label clinical trial will evaluate the safety and efficacy of Alemtuzumab (Campath, Bayer Corp., Pittsburgh) in children (0-17) and adults (18-25) receiving intestinal transplant.
- Conditions
- Evidence of Liver Transplantation, Rejection, ALEMTUZUMAB
- Trial name
- NCT01208337
- Testing
- Alemtuzumab
- Volunteers
- 23 people
- Sponsor
- University of Pittsburgh
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
Renal Failure
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly…
- Trial name
- LCPTacro3002 (NCT01187953)
- Testing
- Prograf (tacrolimus), LCP-Tacro
- Where
- 86 sites in United States, Argentina and 13 more
- Volunteers
- 543 people
- Sponsor
- Veloxis Pharmaceuticals
MDS, Leukemias
Safety Study of Bone Marrow Transplant Using Mismatched Tissue Followed by Chemotherapy
The purpose of this study is to see if giving high dose chemotherapy and total body irradiation before and repeating high dose chemotherapy after a bone marrow transplant could reduce the incidence of graft rejection and disease…
- Conditions
- MDS, Leukemias, Lymphomas
- Trial name
- NCT00796562
- Testing
- Busulfan, Cyclophosphamide, Total body irradiation
- Where
- 2 sites in United States
- Volunteers
- 107 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Renal Transplant Patients
CNS Study of Patients Switching From Tacrolimus to Envarsus
This is a pilot study documenting the neurotoxic side effects including tremors in patients with a stable graft who are receiving Tacrolimus following kidney transplantation.
- Trial name
- NCT03270462
- Testing
- Envarsus XR
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Renal Transplant Rejection, Kidney Transplant Failure and Rejection
Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation
This is a one year, prospective, randomized, open-label trial examining once versus twice daily tacrolimus dosing regimen using two preparations, extended-release Tacrolimus (Envarsus XR) versus twice daily Tacrolimus (Prograf).
- Trial name
- NCT03511560
- Testing
- Tacrolimus Extended Release Oral Tablet, Tacrolimus
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Kidney Transplantation
Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy
The 3C study is investigating whether reducing exposure to calcineurin inhibitors (by using more potent antibody induction treatment and/or an elective switch to sirolimus) can improve the function and survival of kidney…
- Trial name
- 3C (NCT01120028)
- Testing
- Alemtuzumab, Basiliximab, Sirolimus
- Where
- 20 sites in United Kingdom
- Volunteers
- 852 people
- Sponsor
- University of Oxford
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
Hematologic Malignancies
Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation
The purpose of this study is to determine if Velcade (also known as bortezomib) can help prevent graft versus host disease (GVHD) developing after transplantation.
- Trial name
- NCT00369226
- Testing
- Bortezomib (Velcade), Tacrolimus, Methotrexate
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- Dana-Farber Cancer Institute
Graft vs Host Disease, Hematologic Neoplasms
Vorinostat Plus Tacrolimus & Methotrexate to Prevent Graft vs Host Disease Following Unrelated Stem Cell Transplant
This protocol, UMCC 2012.047, was a pilot study initially intended for 12 subjects. After completing enrollment of the planned 12 subjects, we are extending the study to an additional 25 subjects.
- Conditions
- Graft vs Host Disease, Hematologic Neoplasms, Non-Neoplastic Hematologic and Lymphocytic Disorder
- Trial name
- NCT01790568
- Testing
- Vorinostat, Tacrolimus, Methotrexate
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Michigan Rogel Cancer Center