Clinical trials: Transplant Recipients
Transplantation
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive…
- Trial name
- NCT00384137
- Testing
- Tacrolimus
- Where
- 13 sites in France, Germany and 4 more
- Volunteers
- 128 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus
This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with…
- Trial name
- NCT00518375
- Testing
- Rapamune® (Sirolimus), Neoral® (Cyclosporine), Corticosteroids
- Volunteers
- 250 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Sequelae of Viral Hepatitis, Transplantation Infection
Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation
A Phase 2 study to evaluate safety, pharmacokinetics and efficacy of Hepatitis C Immune Globulin Intravenous (human) [Civacir(TM)] for preventing or reducing the impact of recurrent HCV infection following liver transplantation.
- Conditions
- Sequelae of Viral Hepatitis, Transplantation Infection, Evidence of Liver Transplantation
- Trial name
- NCT00473824
- Testing
- Hepatitis C Immune Globulin Intravenous (Human) 5%
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- ADMA Biologics, Inc.
Kidney Transplant Recipients
Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation
This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant
- Trial name
- DART (NCT02424227)
- Where
- 14 sites in United States
- Volunteers
- 401 people
- Sponsor
- CareDx
Kidney Transplantation
Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
- Trial name
- NCT00492869
- Testing
- AEB071
- Where
- 41 sites in United States, Belgium and 5 more
- Volunteers
- 124 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Allograft Injury
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
The main purpose of the study is to investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI).
- Trial name
- NCT04335578
- Testing
- Zampilimab
- Where
- 5 sites in Australia, Belgium and 2 more
- Volunteers
- 3 people
- Sponsor
- UCB Biopharma SRL
Heart Transplantation
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.
- Trial name
- NCT00574743
- Testing
- Enteric-coated Mycophenolate Sodium
- Where
- 9 sites in United States, Argentina and 2 more
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
de Novo Kidney Transplant Recipients, Renal Transplantation
Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.
This study will compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid…
- Trial name
- EVIDENCE (NCT01023815)
- Testing
- everolimus, cyclosporine, Prednison (continuous steroids)
- Where
- 28 sites in Italy
- Volunteers
- 330 people
- Sponsor
- Novartis
Adenovirus
Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia
This is a randomized, controlled, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK), and adenovirus (AdV) antiviral activity of multiple ascending doses of IV brincidofovir (BCV).
- Trial name
- NCT03532035
- Testing
- Brincidofovir, Standard of Care
- Where
- 8 sites in United States, Italy and 1 more
- Sponsor
- Jazz Pharmaceuticals
Liver Transplant
Safety and Efficacy of Perioperative Remodulin® in Orthotopic Liver Transplant Recipients
Patients undergoing orthotopic liver transplant will experience some degree of clinical and/or biochemical hepatic dysfunction. This early injury is known as primary graft dysfunction and varies from minor abnormalities to…
- Trial name
- NCT01884038
- Testing
- treprostinil sodium
- Where
- United States
- Sponsor
- United Therapeutics
Liver Transplantation
A Multicenter Study Evaluating the Safety and Tolerability of Intravenous rhMBL in Liver Transplant Recipients.
This is a multicenter, open-label, randomized, Phase 1B study evaluating liver transplant recipients receiving rhMBL (2 cohorts) or without rhMBL (1 cohort).
- Trial name
- NCT00415311
- Testing
- Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Enzon Pharmaceuticals, Inc.
Ischemia-reperfusion Injury, Kidney Transplant; Complications
A Trial to Assess Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg/ml to Improve Its Function in Recipients of DCD Kidneys
Randomized (1:1), placebo controlled, double blind efficacy trial. 200 patients will be followed up for 12 months post transplantation.
- Trial name
- NCT06582485
- Testing
- iCM012 solution 2 mg/mL
- Volunteers
- 200 people
- Sponsor
- iCoat Medical AB
Liver Transplantation
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
- Trial name
- NCT01888432
- Testing
- Everolimus + reduced tacrolimus, Standard tacrolimus
- Where
- 42 sites in United States, Canada and 11 more
- Volunteers
- 285 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy
The purpose of this study was, starting from the Italian clinical practice in liver transplantation, to optimize the immunosuppressive therapy, considering specific patient characteristics as alcoholic cirrhosis, hepatitis C…
- Trial name
- REFLECT (NCT02115113)
- Testing
- Everolimus, Tacrolimus
- Where
- 14 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Novartis Pharmaceuticals
Cardiac Transplant Failure, Cardiac Transplant Rejection
Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling
Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in association with the measurement of AlloMap, a non-invasive gene expression test to aid in heart transplant management.
- Conditions
- Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases
- Trial name
- D-OAR (NCT02178943)
- Where
- 28 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CareDx
Cytomegalovirus Infections
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis.
- Trial name
- NCT00377741
- Testing
- valganciclovir [Valcyte]
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Hoffmann-La Roche
Kidney Diseases
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to…
- Trial name
- OLYMPE (NCT00284934)
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus, Corticosteroids
- Where
- Switzerland
- Volunteers
- 94 people
- Sponsor
- Novartis
Kidney Transplantation
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
- Trial name
- CIRRUS I (NCT03663335)
- Testing
- CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), Corticosteroids (CS)
- Where
- 74 sites in United States, Argentina and 18 more
- Volunteers
- 418 people
- Sponsor
- Novartis Pharmaceuticals
Bone Marrow Transplantation, Graft Versus Host Disease
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients
- Conditions
- Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Vs-Host Disease, Graft-Versus-Host Disease
- Trial name
- NCT00189761
- Testing
- Tacrolimus
- Where
- 4 sites in Japan
- Sponsor
- Astellas Pharma Inc
Kidney Transplant Recipients, BK Virus
An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients
This study is divided into two parts: ① Part I was a retrospective observational study. Kidney transplant recipients infected with BK virus (BKV) in the First Affiliated Hospital of Sun Yat-sen University from 2015 to 2021 were…
- Trial name
- NCT05293704
- Testing
- Mizoribine
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Lee's Pharmaceutical Limited