Clinical trials: Organ Transplant
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
Lung Diseases
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end…
- Trial name
- NCT03641677
- Testing
- Centralized Lung Evaluation System, Lung Transplant
- Where
- 13 sites in United States
- Volunteers
- 174 people
- Sponsor
- Lung Bioengineering Inc.
Liver Transplant
OCS Liver PROTECT Continued Access Protocol
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
- Trial name
- NCT04186221
- Testing
- OCS Liver System
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- TransMedics
Lung Transplant
US National TOP Registry
The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the…
- Trial name
- NCT06513091
- Testing
- OCS Lung
- Where
- 7 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- TransMedics
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
Actinic Keratosis
A Study to Evaluate the Effectiveness and Safety of Multiple Applications of Imiquimod 5% Cream for the Treatment of Actinic Keratoses in Organ Transplant Recipients
The purpose of the study is to compare effectiveness and safety of multiple applications of imiquimod 5% cream and vehicle cream in graft recipients suffering from actinic keratosis.
- Trial name
- NCT00189267
- Testing
- Imiquimod 5 % Cream
- Volunteers
- 45 people
- Sponsor
- MEDA Pharma GmbH & Co. KG
HCMV Reactivation or HCMV End-Organ Disease
Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).
- Trial name
- NCT01063829
- Testing
- 60 mg AIC246, 120 mg AIC246, 240 mg AIC246
- Where
- 24 sites in United States, Germany
- Volunteers
- 133 people
- Sponsor
- AiCuris Anti-infective Cures AG
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the…
- Conditions
- Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant
- Trial name
- ALLELE (NCT03394365)
- Testing
- tabelecleucel
- Where
- 71 sites in United States, Australia and 7 more
- Volunteers
- 115 people
- Sponsor
- Pierre Fabre Medicament
Lung Transplantation
OCS Lung System EXPAND II Trial
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
- Trial name
- NCT03343535
- Testing
- OCS Lung Preservation
- Where
- 14 sites in United States
- Volunteers
- 46 people
- Sponsor
- TransMedics
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
Organ Preservation
A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation
This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to…
- Trial name
- OPTIMAL (NCT06263023)
- Testing
- Sub-Normothermic Machine Preservation and Assessment
- Where
- 8 sites in United States
- Volunteers
- 80 people
- Sponsor
- 34 Lives, PBC
Pelvic Organ Prolapse
Xenform Postmarket Surveillance Study
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Xenform (NCT01945580)
- Testing
- Prolapse Repair
- Where
- 25 sites in United States
- Volunteers
- 374 people
- Sponsor
- Boston Scientific Corporation
Kidney Transplant; Complications, Liver Transplant; Complications
Medicine Adherence and Effects on Transplants With Pilloxa's Electronic Pillbox
Poor adherence to medication among patients with chronic diseases is a major problem. A patient group where the adherence to prescribed medications is extremely important are organ transplanted patients.
- Trial name
- NCT03848585
- Testing
- Pilloxa Pillbox, Non active Pilloxa Pillbox
- Where
- Sweden
- Volunteers
- 25 people
- Sponsor
- Pilloxa
Kidney Preservation and Transportation
Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation
TB1-K Device is an organ preservation and transportation system, using ultrasound technology with a cooling system to preserve the organ in optimal conditions during transport to the transplant recipient.
- Trial name
- EMERGE (NCT03600285)
- Testing
- TB1-K
- Where
- 3 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Transplant Biomedicals, S.L.
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.
Cytomegalovirus (CMV) Infection, Kidney Transplantation
A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative…
- Trial name
- NCT03629080
- Testing
- HB-101 vaccine
- Where
- 25 sites in United States, Denmark and 4 more
- Volunteers
- 83 people
- Sponsor
- Hookipa Biotech GmbH
Severe Hepatic Veno-Occlusive Disease
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate serum and endothelial markers of…
- Trial name
- NCT00358501
- Testing
- Defibrotide
- Where
- 25 sites in United States, Canada
- Volunteers
- 134 people
- Sponsor
- Jazz Pharmaceuticals
Kidney Transplantation
Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation
This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have…
- Trial name
- NCT00087581
- Testing
- Mycophenolate mofetil, Cyclosporine, Tacrolimus
- Where
- 57 sites in United States
- Volunteers
- 720 people
- Sponsor
- Hoffmann-La Roche
Prevention of Graft Rejection After Organ Transplantation
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3032 in Healthy Subjects
This is a single-center, double-blind, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3032 in healthy adults.
- Trial name
- NCT06090799
- Testing
- SHR-3032
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.