Clinical trials: Kidney Donors
The Rate of Kidney Transplants in Sensitized Patients.
Regional Kidney Paired Donor Exchange in Sensitized Patients
This is a prospective, multi-center, observational study to determine if a combination of desensitization and enrollment in a regional kidney paired donor (KPD) exchange program improves the overall rate of kidney transplantation…
- Trial name
- NCT01896089
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- BiologicTx, LLC
Antibody Mediated Rejection
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization…
- Trial name
- NCT01399593
- Testing
- Eculizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 102 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
KIDNEY TRANSPLANTATION
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids versus tacrolimus plus MMF, following induction with…
- Trial name
- TIGRE (NCT00321113)
- Testing
- tacrolimus, mycophenolate mofetil, steroids
- Where
- 14 sites in Italy
- Volunteers
- 142 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplant, Kidney Failure
Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation
Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors.
- Conditions
- Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures, End Stage Renal Disease (ESRD)
- Trial name
- NEWHOPE (NCT07792317)
- Testing
- Omnisol organ preservation solution
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Vivalyx GmbH
Kidney Failure
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
- Trial name
- NCT00497926
- Testing
- Enriched Hematopoietic Stem Cell Infusion
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Talaris Therapeutics Inc.
Renal Transplantation
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended…
- Trial name
- BENEFIT-EXT (NCT00114777)
- Testing
- Cyclosporin A, Belatacept Less Intensive Regimen (LI), Belatacept More Intensive Regimen (MI)
- Where
- 79 sites in United States, Argentina and 17 more
- Volunteers
- 595 people
- Sponsor
- Bristol-Myers Squibb
Highly Sensitized Patients on Waiting List for Kidney Transplantation
Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
Viela Bio is conducting an open-label, randomized study of inebilizumab, VIB4920, or the combination as part of a multi-center study in highly sensitized patients on the deceased donor waiting list for kidney transplantation.
- Trial name
- NCT04174677
- Testing
- Inebilizumab, VIB4920, Inebilzumab+VIB4920
- Where
- 2 sites in United States
- Sponsor
- Amgen
End Stage Renal Disease
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization.
- Trial name
- NCT02032095
- Testing
- GB-0998
- Where
- Japan
- Volunteers
- 17 people
- Sponsor
- Japan Blood Products Organization
Kidney Transplant Rejection, Cell-free DNA
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.
- Trial name
- NCT07060716
- Testing
- donor-derived cell-free DNA test
- Where
- 10 sites in United States, Germany
- Volunteers
- 125 people
- Sponsor
- Insight Molecular Diagnostics
Renal Failure
Induction of Donor Specific Tolerance in Recipients of Live Donor Kidney Allografts by Donor Stem Cell Infusion
The goal of this research study is to establish chimerism and avoid graft-versus-host disease in patients with kidney failure allowing a reduction or cessation of immune-suppressive therapy.
- Trial name
- NCT00498160
- Testing
- Enriched Hematopoietic Stem Cell Infusion
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Talaris Therapeutics Inc.
Liver Transplantation
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
- Trial name
- NCT01888432
- Testing
- Everolimus + reduced tacrolimus, Standard tacrolimus
- Where
- 42 sites in United States, Canada and 11 more
- Volunteers
- 285 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor.
- Trial name
- NCT01974206
- Testing
- ASP0113
- Where
- 53 sites in United States, Australia and 4 more
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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.
Renal Transplantation
Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice.
- Trial name
- NCT00697112
- Testing
- Sirolimus
- Where
- 8 sites in Argentina
- Volunteers
- 53 people
- Sponsor
- Pfizer
Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection
An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.
A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients.
- Conditions
- Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy
- Trial name
- NCT00235300
- Testing
- Thymoglobulin [Anti-thymocyte Globulin (rabbit)], Simulect (basliximab)
- Where
- 28 sites in United States, France and 3 more
- Volunteers
- 240 people
- Sponsor
- Genzyme, a Sanofi Company
Ischemia-reperfusion Injury, Kidney Transplant; Complications
FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation
A first-in-human single center, randomized, double-blind, placebo-controlled trial, with primary objective to evaluate safety and tolerability of ex-vivo kidney allograft treatment with TUM012 to reduce ischemia-reperfusion…
- Trial name
- NCT05246618
- Testing
- TUM012
- Where
- Sweden
- Volunteers
- 18 people
- Sponsor
- iCoat Medical AB
Kidney Transplantation in Highly Sensitized Patients
Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD).
- Trial name
- DINKY (NCT05753930)
- Testing
- Imlifidase
- Where
- 6 sites in Finland, France and 3 more
- Volunteers
- 10 people
- Sponsor
- Hansa Biopharma AB