Clinical trials: Rejection Acute Renal
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
Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant
Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients
The purpose of this study is to determine if everolimus combined with reduced exposure CNI (TAC) is efficacious and safe and will support corticosteroid elimination compared to a standard exposure CNI (TAC) + MMF + steroid…
- Trial name
- NCT01544491
- Testing
- RAD001, MMF
- Where
- 31 sites in United States, Argentina and 11 more
- Volunteers
- 106 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection.
- Trial name
- NCT00263328
- Testing
- Tacrolimus, CP-690,550
- Where
- 27 sites in United States
- Volunteers
- 46 people
- Sponsor
- Pfizer
Kidney Transplantation
Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids
The 12 Month Core Study (CRAD001A1202) was designed to evaluate the efficacy and safety comparing concentration-controlled everolimus (1.5 mg/day starting dose) with reduced dose cyclosporine and corticosteroids versus 2 g/day…
- Trial name
- NCT00658320
- Testing
- Everolimus, Mycophenolate mofetil (MMF), Basiliximab
- Where
- Japan
- Volunteers
- 122 people
- Sponsor
- Novartis
Kidney Diseases
Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection
The present study investigates the safety and efficacy of steroid withdrawal at six days post-transplant in pediatric renal recipients under concomitant immunosuppression based on antibodies anti IL2 (interleukin 2), Tacrolimus…
- Trial name
- NCT00707759
- Testing
- Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone, Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone
- Where
- Chile
- Volunteers
- 28 people
- Sponsor
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Acute Graft Rejection, Diabetes
A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf
While the incidence of acute rejection and early graft loss have improved dramatically with the advent of newer immunosuppressant medications, improvements in long-term patient and allograft survival after kidney transplantation…
- Trial name
- Astellas (NCT01265537)
- Testing
- Tacrolimus
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of British Columbia
Kidney Transplantation
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with…
- Trial name
- NCT02005562
- Testing
- mycophenolate mofetil, anti-IL-2R, methylprednisolone
- Where
- 24 sites in France
- Volunteers
- 252 people
- Sponsor
- Hoffmann-La Roche
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
Antibody Mediated Rejection
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization…
- Trial name
- NCT01399593
- Testing
- Eculizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 102 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Heart Transplantation
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.
This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant.
- Trial name
- NCT02091414
- Testing
- mycophenolate mofetil (MMF), cyclosporine A (CsA), corticosteroids
- Where
- 3 sites in China
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche
Kidney Transplantation
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the…
- Trial name
- NCT01292226
- Testing
- mycophenolate mofetil, antibody induction, Cyclosporine
- Where
- 7 sites in Italy
- Volunteers
- 45 people
- Sponsor
- Hoffmann-La Roche
Graft Rejection
Randomized Trial for Mixed Acute Rejection
This study is being conducted to determine how safe and effective using an immune cell (b cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are experiencing certain types of rejection.
- Trial name
- NCT00771875
- Testing
- Rabbit Antithymocyte Globulin (RATG), Rituximab, Bortezomib
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Cincinnati
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
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
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
Kidney Transplantation
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients…
- Trial name
- NCT00658359
- Testing
- Cyclosporine, CP-690,550
- Where
- 65 sites in United States, Australia and 13 more
- Volunteers
- 178 people
- Sponsor
- Pfizer
Chronic Allograft Nephropathy, Chronic Kidney Disease
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck.
- Conditions
- Chronic Allograft Nephropathy, Chronic Kidney Disease, Chronic Renal Failure, Disordered Mineral Metabolism
- Trial name
- NCT00975000
- Testing
- Cinacalcet
- Where
- 51 sites in United States, Australia and 9 more
- Volunteers
- 114 people
- Sponsor
- Amgen
Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft
Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate Sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate Mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.
Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.
- Trial name
- MAXIMIZA (NCT01056822)
- Testing
- 1, 2
- Where
- 19 sites in Spain
- Volunteers
- 89 people
- Sponsor
- Novartis 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
Acute Graft Rejection, Chronic Allograft Nephropathy
Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation
After alemtuzumab induction, followed with kidney transplantation, patients will be randomly assigned to receive either tacrolimus or cyclosporine microemulsion in combination with mycophenolates.
- Conditions
- Acute Graft Rejection, Chronic Allograft Nephropathy, Polyomavirus-related Transplant Nephropathy
- Trial name
- RSCS-Campath (NCT01346397)
- Testing
- cyclosporine or tacrolimus
- Where
- Russia
- Volunteers
- 170 people
- Sponsor
- Russian Academy of Medical Sciences