Clinical trials: Acute Rejection of Renal Transplant
Renal Failure
Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
- Trial name
- NCT01666951
- Testing
- LCP-Tacro tablets, Prograf
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- Veloxis Pharmaceuticals
Kidney Transplantation
Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation
Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®.
- Trial name
- OPTIMIZE (NCT02161237)
- Testing
- Advagraf®
- Where
- 2 sites in South Korea, Taiwan
- Volunteers
- 73 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Regimen Optimization Study
Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit…
- Trial name
- NCT02137239
- Testing
- Thymoglobulin, Belatacept, mycophenolate mofetil(MMF)
- Where
- 20 sites in United States, Argentina
- Volunteers
- 58 people
- Sponsor
- Bristol-Myers Squibb
Allografts, Rejection; Transplant, Kidney
A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant
The purpose of this study is to evaluate the efficacy, safety and tolerability of dual costimulation blockade with VIB4920 in combination of belatacept in adult male or female recipients of a renal allograft from a deceased…
- Conditions
- Allografts, Rejection; Transplant, Kidney, Transplant Rejection, Kidney Transplantation
- Trial name
- NCT04046549
- Testing
- Belatacept, VIB4920, Thymoglobulin
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Amgen
Kidney Transplantation
Study of a 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
- NCT00483756
- Testing
- Cyclosporine, CP-690,550
- Where
- 69 sites in United States, Australia and 13 more
- Volunteers
- 338 people
- Sponsor
- Pfizer
Kidney Transplantation
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion…
- Trial name
- NCT00170885
- Testing
- Everolimus
- Where
- Switzerland
- Sponsor
- Novartis
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
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
- Trial name
- NCT01147302
- Testing
- C1 Esterase Inhibitor (Human)
- Where
- 5 sites in United States, Germany
- Volunteers
- 18 people
- Sponsor
- Shire
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 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 Transplant
First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients
This first in human study aims at evaluating LIS1, a stabilized solution of purified anti-T lymphocytes polyclonal glyco-humanized swine IgG with immunosuppressive activity, in regards of safety, T cell depletion, and…
- Trial name
- NCT04431219
- Testing
- LIS1
- Where
- Czechia
- Volunteers
- 10 people
- Sponsor
- Xenothera SAS
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 Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants
This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function.
- Trial name
- NCT02554955
- Testing
- Daclizumab, Mycophenolate mofetil, Silrolimus
- Where
- 14 sites in Spain
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche
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
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
Renal Transplantation, Graft Rejection
A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection.
- Trial name
- NCT00089947
- Testing
- Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Genzyme, a Sanofi Company
Acute Renal Transplant Rejection
NI-0401 in Patients With Acute Renal Allograft Rejection
The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.
- Trial name
- NCT00805909
- Testing
- NI-0401
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Light Chain Bioscience - Novimmune SA
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
Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection
An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.
A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients.
- Conditions
- Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy
- Trial name
- NCT00235300
- Testing
- Thymoglobulin [Anti-thymocyte Globulin (rabbit)], Simulect (basliximab)
- Where
- 28 sites in United States, France and 3 more
- Volunteers
- 240 people
- Sponsor
- Genzyme, a Sanofi Company