Clinical trials: Heart Transplant Recipients
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
Kidney Transplantation, Heart Transplantation
A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics).
- Conditions
- Kidney Transplantation, Heart Transplantation, Liver Transplantation
- Trial name
- OPTION (NCT01371331)
- Testing
- Tacrolimus granules
- Where
- 10 sites in Belgium, France and 4 more
- Volunteers
- 52 people
- Sponsor
- Astellas Pharma Europe Ltd.
Heart Transplant Rejection
Heartsbreath Test for Heart Transplant Rejection
The purpose of this study is to demonstrate and validate a breath test for detection of biomarkers of heart transplant rejection (Grade 2R heart transplant).
- Trial name
- Heartsbreath (NCT01397812)
- Testing
- BreathScanner 1.0, BreathLink
- Where
- 5 sites in United States
- Volunteers
- 1,200 people
- Sponsor
- Menssana Research, Inc.
Cardiac Transplant Failure, Cardiac Transplant Rejection
Outcomes AlloMap Registry: the Long-term Management and Outcomes of Heart Transplant Recipients With AlloMap Testing
The objective of this registry is to observe short and long term clinical outcomes in heart transplant recipients who receive regular AlloMap testing as part of allograft rejection surveillance.
- Conditions
- Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases
- Trial name
- OAR (NCT01833195)
- Where
- 36 sites in United States
- Volunteers
- 2,444 people, healthy volunteers welcome
- Sponsor
- CareDx
Heart Transplantation
A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy.
- Trial name
- NCT00098007
- Testing
- Everolimus (Certican)
- Where
- 28 sites in United States, Australia and 6 more
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
Graft Rejection
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.
- Trial name
- NCT00300274
- Testing
- everolimus, mycophenolate mofetil, cyclosporine
- Where
- 64 sites in United States, Argentina and 13 more
- Volunteers
- 721 people
- Sponsor
- Novartis Pharmaceuticals
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
Heart Transplantation
Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients
Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant.
- Trial name
- NCT00121784
- Testing
- mycophenolate mofetil [CellCept]
- Where
- 29 sites in United States, Australia and 4 more
- Volunteers
- 12 people
- Sponsor
- Hoffmann-La Roche
Graft Rejection, Kidney Failure
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal…
- Trial name
- NCT00369382
- Testing
- cyclosporine or tacrolimus, sirolimus
- Where
- 23 sites in United States, Australia and 5 more
- Volunteers
- 121 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Heart Transplantation
Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in…
- Trial name
- NCT00170859
- Testing
- Everolimus
- Where
- Germany
- Sponsor
- Novartis Pharmaceuticals
Heart Transplantation
Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients
This study will test the safety and efficacy of everolimus on heart transplant recipients. This study is not recruiting in the United States.
- Trial name
- NCT00150046
- Testing
- Everolimus
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 176 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
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.
Lung Transplant
CIS001 Extension Study of Cyclosporine Inhalation Solution
This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.
- Trial name
- CIS002 (NCT00938236)
- Testing
- Cyclosporine Inhalation Solution (CIS)
- Where
- 16 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- APT Pharmaceuticals, Inc.
Lung Transplant
Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation
A Phase III, multi-center, randomized, controlled study designed to demonstrate the efficacy and safety of Cyclosporine Inhalation Solution (CIS)in improving survival and preventing bronchiolitis obliterans syndrome (BOS) when…
- Trial name
- CIS001 (NCT00755781)
- Testing
- Cyclosporine Inhalation Solution (CIS)
- Where
- 19 sites in United States, Canada
- Volunteers
- 284 people
- Sponsor
- APT Pharmaceuticals, Inc.
Cardiac Transplantation
Everolimus in de Novo Heart Transplant Recipients
The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute…
- Trial name
- EVERHEART (NCT01017029)
- Testing
- Everolimus, Mycophenolate mofetil + Everolimus
- Where
- 12 sites in Italy
- Volunteers
- 182 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplant
24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients
The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant…
- Trial name
- EVITA (NCT01169701)
- Testing
- Everolimus, Tacrolimus, Mycophenolic acid (MPA)
- Where
- 9 sites in Spain
- Volunteers
- 71 people
- Sponsor
- Novartis Pharmaceuticals
End-stage Renal Disease
A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
Primary Objective: To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney…
- Trial name
- START-DCD (NCT03099122)
- Testing
- Rabbit Anti-thymocyte Immunoglobulin, Tacrolimus, Methylprednisolone
- Where
- China
- Volunteers
- 115 people
- Sponsor
- Sanofi
Patients Successfully Completing the 12-month Treatment Period of the Core Study (de Novo Heart Recipients) Who Were Interested of Being Treated With EC-MPS
Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Heart Transplant Recipients
This purpose of this extension study of patients being treated with EC-MPS is to assess the long term safety of this medication.
- Trial name
- NCT00238446
- Testing
- EC-MPS
- Sponsor
- Novartis Pharmaceuticals
Graft Rejection
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation. It is usually used in combination with other immunosuppressive drugs such as cyclosporine.
- Trial name
- NCT00097968
- Testing
- everolimus
- Where
- 6 sites in United States
- Sponsor
- Novartis Pharmaceuticals