Clinical trials: Kidney Transplantation Recipients
Renal Transplantation
Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
- Trial name
- NCT01064791
- Testing
- sotrastaurin (Dose 1) + tacrolimus + standard of care medications, sotrastaurin (Dose 2) + tacrolimus + standard of care medications, sotrastaurin (Dose 3) + tacrolimus + standard of care medications
- Where
- 44 sites in United States, Argentina and 13 more
- Volunteers
- 298 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
- Trial name
- NCT00543569
- Testing
- Alefacept, tacrolimus, basiliximab
- Where
- 38 sites in United States
- Volunteers
- 323 people
- Sponsor
- Astellas Pharma Inc
Renal Transplant Recipients With Anti-HLA Antibodies
A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients
The purpose of this treatment registry study is to determine if monthly infusions of Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies that are thought to be responsible for chronic…
- Trial name
- DSA (NCT02115503)
- Where
- 8 sites in United States
- Volunteers
- 52 people
- Sponsor
- Databean
Renal Function, Liver Transplant
Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.
This study was designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.
- Trial name
- NCT01598987
- Testing
- Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.
- Where
- 32 sites in United States, Australia and 10 more
- Volunteers
- 56 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation, Cytomegalovirus Infections
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients.
- Trial name
- NCT01376804
- Testing
- valganciclovir [Valcyte]
- Where
- 25 sites in United States, Australia and 7 more
- Volunteers
- 57 people
- Sponsor
- Hoffmann-La Roche
Renal Transplantation
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
This study will evaluate the safety and efficacy of FTY720 combined with tacrolimus and corticosteroids in patients receiving a kidney transplant
- Trial name
- NCT00239876
- Testing
- FTY720
- Volunteers
- 140 people
- Sponsor
- Novartis Pharmaceuticals
Pediatric Kidney Transplantation
Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to…
- Trial name
- NCT00228020
- Testing
- basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent), MMF, cyclosporine, steroids
- Volunteers
- 212 people
- Sponsor
- Novartis
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
Renal Transplantation
ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients
The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of renal transplant recipients…
- Trial name
- NCT00170846
- Testing
- Everolimus (RAD001), Calcineurin Inhibitors (CNI), Mycophenolate acid (MPA)/Azathioprine (AZA)
- Where
- Switzerland
- Volunteers
- 394 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients
This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in…
- Trial name
- NCT01375127
- Testing
- Tofacitinib
- Where
- 43 sites in United States, Australia and 10 more
- Volunteers
- 83 people
- Sponsor
- Pfizer
Heart Transplantation, Kidney Transplantation
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and…
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- NCT01614665
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 10 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Astellas Pharma Europe Ltd.
Liver Transplantation
Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate…
- Trial name
- RAD (NCT00622869)
- Testing
- Tacrolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination), Tacrolimus (tacrolimus control)
- Where
- 91 sites in United States, Argentina and 17 more
- Volunteers
- 719 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment.
- Trial name
- NCT00332839
- Testing
- Everolimus, Cyclosporin A (CsA), Tacrolimus
- Where
- 11 sites in Germany
- Volunteers
- 93 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients
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
- NCT00556257
- Testing
- Cyclosporine, CP-690-,550
- Sponsor
- Pfizer
Graft Rejection, Kidney Failure
Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12…
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplant
- Trial name
- NCT00266123
- Testing
- Sirolimus
- Volunteers
- 420 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplantation
Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community Clinics
This is a multicentre, observational, non-interventional, retrospective analysis by chart review.
- Trial name
- NCT00902980
- Testing
- Chart Review
- Where
- 13 sites in Canada
- Volunteers
- 264 people
- Sponsor
- Astellas Pharma Inc
Renal Transplantation
Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.
- Trial name
- NCT00241059
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Volunteers
- 183 people
- Sponsor
- Novartis
Renal Function
Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients
This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy
- Trial name
- NCT00634920
- Testing
- everolimus, cyclosporine A, Enteric Coated Mycophenolate Sodium (EC-MPS)
- Where
- 8 sites in Denmark, Norway and 1 more
- Volunteers
- 204 people
- Sponsor
- Novartis Pharmaceuticals
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.
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.