Clinical trials: Renal Transplant Recipient
Kidney Transplantation
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate…
- Trial name
- INTAC (NCT00113269)
- Testing
- basiliximab, rabbit anti-thymocyte globulin, tacrolimus
- Where
- 29 sites in United States
- Volunteers
- 501 people
- Sponsor
- Astellas Pharma Inc
Graft Rejection, Kidney Transplantation
Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney
The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better…
- Conditions
- Graft Rejection, Kidney Transplantation, Renal Transplantation
- Trial name
- NCT00035555
- Testing
- Belatacept, Cyclosporine, Mycophenolate mofetil (MMF)
- Where
- 12 sites in United States
- Volunteers
- 230 people
- Sponsor
- Bristol-Myers Squibb
Cytomegalovirus Disease
A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.
- Trial name
- NCT04225923
- Testing
- NPC-21 Low dose, NPC-21 High dose
- Where
- 28 sites in United States, Japan
- Volunteers
- 87 people
- Sponsor
- Nobelpharma
Kidney Transplantation
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT06365437
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 7 sites in Austria, Spain and 1 more
- Volunteers
- 33 people
- Sponsor
- ITB-Med LLC
Cardiac Transplantation
Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.
The purpose of the study is to determine the extent of cyclosporine microemulsion dose reduction required to maintain stable renal function in maintenance cardiac transplant recipients, after initiation of everolimus.
- Trial name
- NCT00170794
- Testing
- Everolimus (RAD001)
- Sponsor
- Novartis Pharmaceuticals
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
COVID-19
Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine
This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co.
- Trial name
- NCT05285384
- Testing
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Where
- Iran
- Volunteers
- 43 people
- Sponsor
- Cinnagen
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 cyclosporine and corticosteroids in patients receiving a kidney organ transplant
- Trial name
- NCT00239785
- Testing
- FTY720
- Volunteers
- 684 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.
- Trial name
- NCT01820572
- Testing
- Belatacept, Tacrolimus, Cyclosporine
- Where
- 117 sites in United States, Argentina and 8 more
- Volunteers
- 446 people
- Sponsor
- Bristol-Myers Squibb
Renal Transplantation
Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study)
The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to demonstrate that saturation and expression…
- Trial name
- IDEALE (NCT01596062)
- Testing
- Simulect®, Neoral®, Certican®
- Where
- 3 sites in France
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
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
Kidney Transplantation
A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients
The purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of ASP8597 in kidney transplant recipients.
- Trial name
- NCT01442337
- Testing
- ASP8597
- Where
- 19 sites in United States
- Volunteers
- 21 people
- Sponsor
- Astellas Pharma Inc
Antibody-mediated Rejection
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)
The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation.
- Trial name
- Shamrock (NCT06503731)
- Testing
- Efgartigimod PH20 SC - prefilled syringe
- Where
- 23 sites in United States, Austria and 6 more
- Volunteers
- 33 people
- Sponsor
- argenx
Kidney Transplantation, Transplantation, Kidney
Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients
To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation To estimate the…
- Trial name
- NCT01656343
- Testing
- Calcineurin inhibitors (CNI), Belatacept
- Volunteers
- 775 people
- Sponsor
- Bristol-Myers Squibb
Kidney Transplant
Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients
The purpose of this study is to confirm non-inferiority of delayed Prograf treatment to standard Prograf treatment in the incidence of delayed graft function (DGF) within 1 week between the 2 immunosuppressive (IS) treatment…
- Trial name
- NCT03644485
- Testing
- Tacrolimus immediate-release formulation, Tacrolimus prolonged-release formulation, Induction therapy
- Where
- 14 sites in China
- Volunteers
- 284 people
- Sponsor
- Astellas Pharma China, 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
Liver Transplantation
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.
- Trial name
- HEPHAISTOS (NCT01551212)
- Testing
- Everolimus, Tacrolimus, Corticosteroids
- Where
- 15 sites in Germany
- Volunteers
- 339 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplant Failure and Rejection
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
The goal of this clinical trial is to learn if siplizumab can prevent rejection of a kidney transplant in adult participants with end stage kidney disease.
- Trial name
- MODERNIZE1 (NCT07508787)
- Testing
- Siplizumab, Rabbit anti-thymocyte globulin
- Where
- 24 sites in United States, Brazil and 1 more
- Volunteers
- 120 people
- Sponsor
- Nefro Avillion Clinical Development, LLC
Heart Transplantation
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which…
- Trial name
- MANDELA (NCT00862979)
- Testing
- Everolimus (EVR), cyclosporine A (CyA), tacrolimus (TAC)
- Where
- 9 sites in Germany
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation.
- Trial name
- NCT01780844
- Testing
- ASKP1240, Tacrolimus, Mycophenolate Mofetil (MMF)
- Where
- 42 sites in United States
- Volunteers
- 149 people
- Sponsor
- Astellas Pharma Global Development, Inc.