Clinical trials: Organ Rejection Transplants
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 Transplantation
A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients
An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.
- Trial name
- FREEDOM-2 (NCT01649388)
- Testing
- FCR001
- Where
- 3 sites in United States
- Sponsor
- Talaris Therapeutics Inc.
Organ Transplant Rejection, Psoriasis
Safety and Pharmacokinetics of Sustained-release Depot Tacrolimus: A First-in-human Study
This first-in-human study is designed to assess the safety and pharmacokinetic (PK) profile of sustained-release (SR) depot tacrolimus, which will be administered as a single dose of 0.1 mg/kg by subcutaneous (SC) injection in…
- Trial name
- NCT03626714
- Testing
- Sustained Release Injectable Tacrolimus
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Auritec Pharmaceuticals
Heart Transplantation, Kidney Transplantation
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and…
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- NCT01614665
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 10 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Astellas Pharma Europe Ltd.
Infection in Solid Organ Transplant Recipients
T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays
The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T cells [spot forming cells/million peripheral blood mononuclear cells - PBMC)].
- Trial name
- PROTECT (NCT02382211)
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 600 people
- Sponsor
- Oxford Immunotec
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
Transplant Rejection, Renal Transplantation
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China for prophylaxis of organ rejection in renal transplantation.
- Trial name
- NCT01236378
- Testing
- Sirolimus
- Where
- 2 sites in China
- Volunteers
- 24 people
- Sponsor
- Pfizer
Coronary Heart Disease
Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus
The purpose of this observational protocol is to evaluate the use of everolimus in routine clinical practice for heart transplants. Primary outcome measures: incidence of acute rejection episodes Secondary outcomes: safety
- Trial name
- NCT00134940
- Where
- 6 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- Novartis
Kidney Transplantation
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor…
- Trial name
- RETIRE (NCT06552169)
- Testing
- Arm 1: SOC (mTOR + CNI), Arm 2A: TRACT/MONO mTOR, Arm 2B: TRACT/MONO CNI
- Where
- 7 sites in United States, Taiwan
- Volunteers
- 34 people
- Sponsor
- Singulera Therapeutics Inc.
Transplanted Organ Rejection
A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation
A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.
- Trial name
- FREEDOM-1 (NCT03995901)
- Testing
- FCR001
- Where
- 18 sites in United States
- Volunteers
- 15 people
- Sponsor
- Talaris Therapeutics Inc.
Influenza
Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK
This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.
- Trial name
- NCT01715792
- Testing
- Data collection
- Where
- United Kingdom
- Volunteers
- 587 people
- Sponsor
- GlaxoSmithKline
Solid Organ Transplant Rejection, COVID-19
AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience
The utilization of AlloSure to help guide immunosuppression management in solid organ transplant recipients diagnosed with COVID-19
- Trial name
- Al-COVE (NCT04341103)
- Volunteers
- 500 people
- Sponsor
- CareDx