Clinical trials: Kidney Donors
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.
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.
Delayed Graft Function
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function.
- Trial name
- VARVARA (NCT05907096)
- Testing
- ARGX-117
- Where
- 45 sites in United States, Australia and 9 more
- Volunteers
- 103 people
- Sponsor
- argenx
Delayed Graft Function, Other Complications of Kidney Transplant
Biomarkers of Aging as Predictors of Kidney Transplant Function
The primary purpose of this study is to measure the correlation between baseline expression of aging biomarkers, SenesceTest in blood of organ donor and renal graft function.
- Trial name
- NCT02335333
- Testing
- No treatment
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Sapere Bio
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
Kidney Transplant, Immunosuppression
KidneyCare Immuno-optimization in Renal Allografts (KIRA)
This is an unblinded, randomized, four-arm interventional research study enrolling patients who are undergoing kidney transplantation.
- Conditions
- Kidney Transplant, Immunosuppression, Allograft
- Trial name
- NCT05423496
- Testing
- KidneyCare, steroid, MMF
- Sponsor
- CareDx
Transplant Rejection, Allograft Rejection
Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis…
- Conditions
- Transplant Rejection, Allograft Rejection, Complications
- Trial name
- SPARO (NCT03984747)
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Natera, 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 Rejection
An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients
The purpose of this study was to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have had an…
- Trial name
- NCT03897205
- Testing
- Imlifidase, Plasma Exchange
- Where
- 14 sites in United States, Australia and 3 more
- Volunteers
- 30 people
- Sponsor
- Hansa Biopharma AB
Kidney Transplant Rejection
Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor Kidney Transplants
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen (HLA)-matched, living…
- Trial name
- NCT03606746
- Testing
- MDR-103
- Sponsor
- Medeor Therapeutics, Inc.
Kidney Transplant Rejection
Cellular Immunotherapy in Recipients of Human Leukocyte Antigen (HLA)-Mismatched, Living Donor Kidney Transplants
The Phase 2 primary objective is to evaluate achievement of persistent mixed chimerism and withdrawal of at least one immunosuppression drug for a minimum of 6 months with no episodes of biopsy-proven acute rejection or…
- Trial name
- NCT03605654
- Testing
- MDR-102, Immunosuppressive Agents
- Sponsor
- Medeor Therapeutics, Inc.
Kidney Transplant Rejection
Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living…
- Trial name
- NCT03363945
- Testing
- MDR-101
- Where
- 19 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Medeor Therapeutics, Inc.
Kidney Transplantation
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)
The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor…
- Trial name
- NCT04803006
- Testing
- TCD601
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- ITB-Med LLC
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
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
Renal Allograft Recipients
A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications
The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to…
- Trial name
- NCT04877288
- Testing
- Belatacept, Tacrolimus, Cyclosporine A
- Where
- 38 sites in United States, Argentina and 8 more
- Volunteers
- 102 people
- Sponsor
- Bristol-Myers Squibb
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 Transplant Recipients
Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation
This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant
- Trial name
- DART (NCT02424227)
- Where
- 14 sites in United States
- Volunteers
- 401 people
- Sponsor
- CareDx
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