Clinical trials: Transplantation, Kidney
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
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
Antibody-mediated Rejection
Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
- Trial name
- NCT03221842
- Testing
- C1-esterase inhibitor
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 63 people
- Sponsor
- CSL Behring
Hepatitis B
Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion…
- Trial name
- NCT01590615
- Testing
- Anti-HBV nucleoside/nucleotide therapy
- Where
- 27 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Gilead Sciences
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
De Novo Kidney Transplantation
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and…
- Trial name
- NCT00617604
- Testing
- Alefacept, Tacrolimus, Mycophenolate Mofetil
- Where
- 33 sites in Austria, Belgium and 10 more
- Volunteers
- 218 people
- Sponsor
- Astellas Pharma Inc
Viruria
CMX001 in Post-transplant Patients With BK Virus Viruria
This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus viruria.
- Trial name
- NCT00793598
- Testing
- Brincidofovir
- Where
- 15 sites in United States
- Volunteers
- 29 people
- Sponsor
- Jazz Pharmaceuticals
De Novo Renal Transplantation
Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients
To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in de novo renal transplant recipients by assessing rejection rate everolimus trough levels, other safety laboratory variables and adverse…
- Trial name
- NCT00464399
- Testing
- everolimus
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended…
- Trial name
- BENEFIT-EXT (NCT00114777)
- Testing
- Cyclosporin A, Belatacept Less Intensive Regimen (LI), Belatacept More Intensive Regimen (MI)
- Where
- 79 sites in United States, Argentina and 17 more
- Volunteers
- 595 people
- Sponsor
- Bristol-Myers Squibb
Renal Transplantation
Study Evaluating Rapamune in Patients After Kidney Transplantation
The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions
- Trial name
- NCT00240214
- Testing
- sirolimus
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplantation
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)
The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor…
- Trial name
- NCT04803006
- Testing
- TCD601
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- ITB-Med LLC
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
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
Renal Failure
Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)
- Trial name
- NCT02051673
- Testing
- Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion
- Where
- United States
- Sponsor
- Talaris Therapeutics Inc.
Delayed Graft Function
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function.
- Trial name
- VARVARA (NCT05907096)
- Testing
- ARGX-117
- Where
- 45 sites in United States, Australia and 9 more
- Volunteers
- 103 people
- Sponsor
- argenx
Renal Transplantation
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects
- Trial name
- NCT02564497
- Testing
- Process E Belatacept, Process C Belatacept
- Where
- United States
- Volunteers
- 491 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Graft Rejection, Kidney Failure
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction…
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplantation
- Trial name
- NCT00261820
- Testing
- tacrolimus, mycophenolate mofetil, methylprednisolone
- Volunteers
- 160 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer