Clinical trials: Rejection
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
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
Kidney Transplantation, Graft Rejection
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.
- Trial name
- NCT00251004
- Testing
- Everolimus, Mycophenolic Acid (MPA), Cyclosporine A (CsA)
- Where
- United States
- Volunteers
- 833 people
- Sponsor
- Novartis
Kidney Transplant Rejection
TruGraf® Testing in High-Risk Kidney Transplant Recipients
This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney…
- Trial name
- NCT04266613
- Testing
- TruGraf® Testing
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Transplant Genomics, Inc.
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 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.
Kidney Transplant Rejection
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing…
- Trial name
- FREXERA (NCT07412470)
- Testing
- Frexalimab, Tacrolimus, rabbit anti-thymocyte globulin
- Where
- 73 sites in United States, Argentina and 16 more
- Volunteers
- 526 people
- Sponsor
- Sanofi
Fuchs' Dystrophy, Bullous Keratopathy
Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)
The purpose of this study is to compare two different commonly used steroid dosing regimens after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery.
- Trial name
- NCT01448213
- Testing
- Prednisolone acetate, Fluorometholone
- Where
- 2 sites in United States, Germany
- Volunteers
- 264 people
- Sponsor
- Price Vision Group
Bronchiolitis Obliterans, Lung Transplant Rejection
Transplant Optimization Using Functional Imaging
The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early stage using the outcome parameters generated by Functional Respiratory Imaging (FRI).
- Trial name
- TROFI (NCT02364674)
- Testing
- High Resolution Computed Tomography scan
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- FLUIDDA nv
Kidney Diseases, Kidney Injury
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and/or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney…
- Conditions
- Kidney Diseases, Kidney Injury, BK Virus Infection, CMV
- Trial name
- ID-ENTITY (NCT07393594)
- Testing
- Blood tests, TRAC( cell free DNA) and T-ID
- Where
- 14 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Transplant Genomics, Inc.
Kidney Transplantation
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with…
- Trial name
- NCT02005562
- Testing
- mycophenolate mofetil, anti-IL-2R, methylprednisolone
- Where
- 24 sites in France
- Volunteers
- 252 people
- Sponsor
- Hoffmann-La Roche
Immunosuppression Management, Biomarkers / Blood
PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)
This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring. Approximately 15 U.S. sites
- Conditions
- Immunosuppression Management, Biomarkers / Blood, Subclinical Rejection, Biopsy
- Trial name
- PIONEER (NCT07231328)
- Testing
- There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.
- Volunteers
- 600 people
- Sponsor
- Transplant Genomics, Inc.
Solid Organ Transplant Rejection, Organ Rejection Transplants
Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients
This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression…
- Conditions
- Solid Organ Transplant Rejection, Organ Rejection Transplants, Organ Rejection
- Trial name
- NCT05215288
- Testing
- ExoFlo
- Where
- 2 sites in United States
- Sponsor
- Direct Biologics, LLC
Kidney Transplant Failure and Rejection
Assessment of QSant™ for Underlying Allograft Rejection
The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test.
- Trial name
- AQUA (NCT05282966)
- Testing
- QSant-TM Urine Test
- Volunteers
- 4,000 people
- Sponsor
- NephroSant
Liver Dysfunction, Rejection, Transplant
Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection.
- Conditions
- Liver Dysfunction, Rejection, Transplant, Transplantation, Liver
- Trial name
- NCT00117689
- Testing
- Thymoglobulin, Corticosteroid, Tacrolimus
- Where
- 16 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Genzyme, a Sanofi Company
Kidney Transplant Rejection
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
- Trial name
- NCT06126380
- Testing
- AT-1501, Tacrolimus
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 132 people
- Sponsor
- Eledon Pharmaceuticals
Antibody Mediated Rejection
A Two Part Dose-escalation Safety and Efficacy Study of CID-103 in Adults With Active and Chronic Active Renal Allograft Antibody Mediated Rejection (ABMR).
The goal of the global Phase 1/2 clinical trial is to evaluate whether CID-103, a novel anti-CD38 monoclonal antibody, is safe and effective in adults with with active and chronic active renal allograft antibody mediated…
- Trial name
- NCT07641426
- Testing
- CID-103
- Where
- 4 sites in China
- Volunteers
- 58 people
- Sponsor
- CASI pharmaceuticals, Inc.
Chronic Heart Failure
Impact of Formulary Coverage of Entresto (Sacubitril/Valsartan) on Prescription Abandonment/Rejection and Subsequent Treatment and Economic Outcomes in Chronic Heart Failure Patients in the U.S.
This was a retrospective cohort study utilizing IQVIA open-source pharmacy and medical claims data among patients with a sacubitril/valsartan (SAC/VAL) prescription transaction.
- Trial name
- NCT05848206
- Where
- United States
- Volunteers
- 251,831 people
- Sponsor
- Novartis Pharmaceuticals
Prevention of Rejection in Kidney Transplant
Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
- Trial name
- NCT05027906
- Testing
- AT-1501
- Where
- 9 sites in United States, Australia and 3 more
- Volunteers
- 48 people
- Sponsor
- Eledon Pharmaceuticals
Kidney Transplantation
A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.
The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.
- Trial name
- ADHERE (NCT01363752)
- Testing
- Advagraf, Mycophenolate Mofetil, Sirolimus
- Where
- 58 sites in Australia, Austria and 15 more
- Volunteers
- 853 people
- Sponsor
- Astellas Pharma Inc