Clinical trials: Heart Transplant Rejection
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
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
Heart Transplant, Acute Graft Rejection
Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction
The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft dysfunction in contrast to those with normal…
- Conditions
- Heart Transplant, Acute Graft Rejection, Chronic Graft Rejection
- Trial name
- NCT02597543
- Testing
- Regadenoson, Gadolinium, Cardiac MRI
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Paul Kim
Heart Transplant Failure and Rejection
Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant
Immunosuppressive therapy is required to prevent organ rejection, however, dosing of immunosuppressive agents is complicated by patient-specific differences impacting the body's absorption and elimination of these agents.
- Trial name
- NCT04380311
- Testing
- Tacrolimus Dosing Support Tool
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- University of Utah
Heart Diseases, Heart Transplantation
Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
- Trial name
- NCT00157014
- Testing
- Tacrolimus, Cyclosporine, Mycophenolate mofetil
- Where
- 13 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Astellas Pharma Inc
Immunosuppression
Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.
- Trial name
- TICTAC (NCT00299221)
- Testing
- Tacrolimus, combination therapy
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Newark Beth Israel Medical Center
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
Pediatric Heart Transplantation, Immunosuppression
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years.
- Conditions
- Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy
- Trial name
- TEAMMATE (NCT03386539)
- Testing
- Everolimus, Tacrolimus, Mycophenolate Mofetil
- Where
- 25 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Children's Hospital
Acute Graft Rejection
Magnetic Resonance Elastography of Cardiac Transplant Rejection
Magnetic Resonance Elastography (MRE) for cardiac transplant patients.
- Trial name
- NCT02266914
- Testing
- Magnetic Resonance Elastography driver
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Ohio State University
Heart Transplantation
SCHEDULE Follow Up Visit 5-7 yr
The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary…
- Trial name
- CRAD001ANO05 (NCT02864706)
- Testing
- Everolimus, Cyclosporine, Mycophenolate mofetil
- Where
- 6 sites in Denmark, Norway and 1 more
- Volunteers
- 95 people
- Sponsor
- Novartis Pharmaceuticals
Antibody-mediated Rejection, Hyperacute Rejection of Cardiac Transplant
The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation
All individuals who receive a heart transplant are at risk for developing antibody-mediated rejection (AMR). An antibody is a protein produced by the body's immune system when it detects a foreign substance, called an antigen.
- Conditions
- Antibody-mediated Rejection, Hyperacute Rejection of Cardiac Transplant, Left Ventricular Dysfunction, Cardiac Allograft Vasculopathy
- Trial name
- DUET (NCT02013037)
- Testing
- Eculizumab
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Cedars-Sinai Medical Center
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