Clinical trials: Kidney Transplant Immunosuppression
Kidney Transplantation
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282568
- Testing
- Tacrolimus Modified Release (MR), tacrolimus
- Where
- 9 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Inc
Heart Transplantation, Liver Transplantation
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record…
- Conditions
- Heart Transplantation, Liver Transplantation, Kidney Transplantation
- Trial name
- NCT02118896
- Testing
- FK506E
- Where
- 105 sites in United States, Australia and 21 more
- Volunteers
- 850 people
- Sponsor
- Astellas Pharma Europe Ltd.
Graft Rejection
Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation
The purpose of this research study is to compare the effects of the two most commonly used anti-T cell induction agents(alemtuzumab and rabbit anti-thymocyte globulin) to prevent rejection in kidney and pancreas transplant…
- Trial name
- NCT00331162
- Testing
- Alemtuzumab, Anti-Thymocyte Globulin
- Where
- United States
- Volunteers
- 222 people
- Sponsor
- Wake Forest University Health Sciences
Renal Transplant
Belatacept to Prevent Organ Rejection in Kidney Transplant Patients
Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had renal (e.g., kidney) transplants.
- Trial name
- BESTT (NCT00346151)
- Testing
- Belatacept, Sirolimus, Anti-thymocyte globulin
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Kidney Transplantation
Everolimus in de Novo Kidney Transplant Recipients
The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate…
- Trial name
- NEVERWOUND (NCT01410448)
- Testing
- Everolimus, Mycophenolate sodium, Cyclosporine
- Where
- 22 sites in Italy
- Volunteers
- 383 people
- Sponsor
- Novartis Pharmaceuticals
Stable Renal Transplant Recipients
Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients
The purpose of the study is to further investigate how much of the drug substance "mycophenolate mofetil" can be found in the blood of patients with kidney or renal transplants when treated with Myfenax® or CellCept®.
- Trial name
- NCT00991510
- Testing
- mycophenolate mofetil (Myfenax), mycophenolate mofetil (Cellcept)
- Volunteers
- 43 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
End Stage Renal Disease, Rejection of Renal Transplant
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
The overall aim of the study is to prospectively investigate the impact of two maintenance calcineurin inhibitor immunosuppressive regimens: once-daily extended release tacrolimus and twice-daily tacrolimus on subpopulations of T…
- Trial name
- NCT03289650
- Testing
- Tacrolimus, Tacrolimus Extended Release Oral Tablet [Envarsus]
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Lorenzo Gallon
Immunosuppression, Kidney Transplantation
HLA-Identical Sibling Renal Transplant Tolerance
The purpose of this study is to attempt to eliminate the necessity of immunosuppressive therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor hematopoietic stem cell (DHSC) lineages for pairs…
- Conditions
- Immunosuppression, Kidney Transplantation, Graft Rejection
- Trial name
- NCT00619528
- Testing
- Infusion of Donor Hematopoietic Stem Cells and Campath-1H
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Kidney Failure, Chronic, Diabetic Nephropathies
Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.
This is a 12-month, phase II, prospective, open label study, to evaluate the effect of mycophenolate mofetil (MMF) among patients on the kidney transplant list with high Panel of Reactive Antibody (PRA) levels.
- Conditions
- Kidney Failure, Chronic, Diabetic Nephropathies, Glomerulonephritis, IGA, Hypertension, Renal
- Trial name
- NCT00446459
- Testing
- mycophenolate mofetil (CellCept)
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- University of Washington
Kidney Diseases
Study of ISA247 (Voclosporin) in De Novo Renal Transplantation
This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.
- Trial name
- PROMISE (NCT00270634)
- Testing
- Voclosporin, tacrolimus
- Where
- 45 sites in United States, Canada
- Volunteers
- 334 people
- Sponsor
- Aurinia Pharmaceuticals 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 Failure, Graft Rejection
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
The current anti-rejection drug regime for kidney transplant recipients in use at the West London Renal \& Transplant Centre (WLRaTC) consists of induction therapy with the very potent monoclonal antibody Campath 1-H…
- Trial name
- TAESR (NCT00807144)
- Testing
- Tacrolimus (Kidney transplant maintenance immunosuppression), Kidney transplant maintenance immunosuppression
- Where
- United Kingdom
- Volunteers
- 102 people
- Sponsor
- Imperial College Healthcare NHS Trust
Kidney Transplant Immunosuppression
Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune…
- Trial name
- NCT04786067
- Testing
- Belatacept
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Texas Southwestern Medical Center
Kidney Failure
Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus.
- Trial name
- NCT04258423
- Testing
- Tacrolimus, Everolimus
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
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 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
Renal Transplant
24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients
The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant…
- Trial name
- EVITA (NCT01169701)
- Testing
- Everolimus, Tacrolimus, Mycophenolic acid (MPA)
- Where
- 9 sites in Spain
- Volunteers
- 71 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
- Trial name
- NCT00658333
- Testing
- Enteric-coated Mycophenolate Acid (EC-MPA), Mycophenolate Mofetil (MMF)
- Where
- 37 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Renal Failure
Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules…
- Trial name
- NCT00817206
- Testing
- LCP-Tacro, Prograf
- Where
- United States
- Volunteers
- 326 people
- Sponsor
- Veloxis Pharmaceuticals