Clinical trials: Transplantation
Kidney Transplantation
A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation
The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.
- Trial name
- NCT01279538
- Testing
- bleselumab
- Where
- 21 sites in United States
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc
Acute Myeloid Leukemia, Stem Cell Transplantation
Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT.
- Trial name
- ARTEMIS (NCT04511130)
- Testing
- MT-401
- Where
- 18 sites in United States
- Volunteers
- 92 people
- Sponsor
- Marker Therapeutics, Inc.
Kidney Transplantation in Highly Sensitized Patients
A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation
The purpose of this study is to assess whether imlifidase in combination with bortezomib, belatacept, rituximab and IVIg can suppress donor specific antibodies (DSA) and the occurrence of antibody-mediated rejection (AMR) in…
- Trial name
- NCT05049850
- Testing
- Imlifidase
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Hansa Biopharma AB
Lung Transplantation
OCS™ Lung TOP Registry For Donor Lungs for Transplantation
Single-arm, prospective, multi-center, post-approval U.S. registry
- Trial name
- TOP (NCT03639025)
- Testing
- OCS Lung System
- Where
- 18 sites in United States
- Volunteers
- 458 people
- Sponsor
- TransMedics
Skin Transplantation
Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®)
FibDex® 2-2022 is a sponsored, post-marketing clinical follow-up (PMCF) study to monitor the clinical performance and safety of the CE marked product nanofibrillar cellulose (NFC) wound dressing, FibDex®, when used according to…
- Trial name
- NCT05666999
- Testing
- FibDex®, Suprathel, Aquacel Foam
- Where
- Finland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- UPM-Kymmene Corporation
Acute Myeloid Leukemia, Allogeneic Stem Cell Transplantation
A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant
The purpose of this study was to confirm a safe dose and schedule as well as the preliminary efficacy of siremadlin alone, and in combination with donor lymphocyte infusion (DLI), in adult participants with Acute Myeloid Leukemia…
- Trial name
- NCT05447663
- Testing
- Siremadlin
- Where
- 6 sites in Germany, Italy and 1 more
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
WP02 Continued Access Study
The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.
- Trial name
- NCT04862156
- Testing
- Normothermic Machine Perfusion (NMP)
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- OrganOx Ltd.
Kidney Transplantation
Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation
In this clinical trial the investigational medicinal product MIC is to be examined for its efficacy and safety in patients with living kidney transplantation.
- Trial name
- NCT05365672
- Testing
- MIC, Standard of Care
- Where
- 8 sites in Germany
- Volunteers
- 126 people
- Sponsor
- TolerogenixX GmbH
Lung Transplantation
Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation
The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria.
- Trial name
- HELP (NCT01190059)
- Testing
- Ex vivo lung perfusion with Steen Solution™
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- XVIVO Perfusion
Liver Transplantation
OrganOx Metra® New Enrollment PAS
The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current…
- Trial name
- NCT05526326
- Testing
- Transplant with normothermic machine perfused (NMP) donor liver
- Where
- 10 sites in United States
- Volunteers
- 315 people
- Sponsor
- OrganOx Ltd.
Thrombotic Microangiopathies, Hematopoietic Stem Cell Transplantation
Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA
The purpose of this study is to evaluate the safety and efficacy of narsoplimab in pediatric patients with thrombotic microangiopathies (TMA) following hematopoietic stem cell transplant (HSCT).
- Trial name
- NCT05855083
- Testing
- Biological: narsoplimab
- Where
- 16 sites in United States, Germany and 3 more
- Volunteers
- 18 people
- Sponsor
- Omeros Corporation
Hepato Cellular Carcinoma (HCC), Liver Resection
Retrospective Clinical Validation of HepatoPredict
HepatoPredict is an innovative prognostic tool to support hepatologists, hepatobiliary surgeons and multidisciplinary teams in deciding on the best therapeutical approach for a patient with Hepatocellular Carcinoma, the most…
- Conditions
- Hepato Cellular Carcinoma (HCC), Liver Resection, Liver Transplantation
- Trial name
- NCT06894524
- Volunteers
- 200 people
- Sponsor
- Ophiomics
Liver Transplantation, Kidney Transplantation
A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
The purpose of this study is to determine the pharmacokinetics of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in pediatric participants undergoing de novo allograft liver or…
- Trial name
- NCT05152628
- Testing
- Tacrolimus granules
- Where
- 4 sites in China
- Volunteers
- 55 people
- Sponsor
- Astellas Pharma China, Inc.
Liver Transplantation, Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.
- Trial name
- NCT05153915
- Testing
- Tacrolimus granules
- Where
- 7 sites in China
- Volunteers
- 56 people
- Sponsor
- Astellas Pharma China, Inc.
Kidney Transplantation
A Dose Escalation Study in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT04311632
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- ITB-Med LLC
Poor Thymic Function, Immunodeficiency
Expanded Access Protocol Thymus Transplantation
The primary purpose is to provide access for patients who have immunodeficiency or severe autoimmune disease related to poor thymic function to cultured thymus tissue for implantation.
- Conditions
- Poor Thymic Function, Immunodeficiency, Athymia, Immunoreconstitution
- Trial name
- NCT02274662
- Testing
- Cultured Thymus Tissue, Blood Draw, Rabbit Anti-Thymocyte Globulin and Cyclosporine or Tacrolimus
- Volunteers
- 11 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Allografts, Rejection; Transplant, Kidney
A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant
The purpose of this study is to evaluate the efficacy, safety and tolerability of dual costimulation blockade with VIB4920 in combination of belatacept in adult male or female recipients of a renal allograft from a deceased…
- Conditions
- Allografts, Rejection; Transplant, Kidney, Transplant Rejection, Kidney Transplantation
- Trial name
- NCT04046549
- Testing
- Belatacept, VIB4920, Thymoglobulin
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Amgen
Kidney Transplantation
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
This study compared the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of immune activation (IA) on peripheral blood molecular profiling in participants…
- Trial name
- ASTOUND (NCT02723591)
- Testing
- Tacrolimus, Tacrolimus immediate release
- Where
- 30 sites in United States
- Volunteers
- 599 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Ischemia-Reperfusion Injury, Lung Transplantation
Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
The objective of this clinical study was to evaluate whether CXCL8 (CXC ligand 8 [formerly interleukin (IL)-8]) inhibition with repertaxin leads to reduced severity of primary graft dysfunction, as the result of improved…
- Trial name
- NCT00224406
- Testing
- Repertaxin
- Where
- 6 sites in United States, Canada
- Volunteers
- 114 people
- Sponsor
- Dompé Farmaceutici S.p.A
Kidney Transplantation, Primary Focal Segmental Glomerulosclerosis (FSGS)
Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
The purpose of this study was to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus…
- Trial name
- NCT02921789
- Testing
- Bleselumab, Basiliximab, Mycophenolate Mofetil (MMF)
- Where
- 23 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Astellas Pharma Global Development, Inc.