Clinical trials: Kidney Donor
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
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
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.
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 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.
Stage V Chronic Kidney Disease
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
- Trial name
- NCT01567085
- Testing
- Eculizumab
- Where
- 15 sites in Australia, France and 4 more
- Volunteers
- 80 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Normothermic Machine Perfusion (NMP) of Deceased Donor Kidneys
Registry Analysis of Deceased Donor Kidney Transplant Outcomes
This study uses existing transplant data obtained from a national public donor registry operated by the Organ Procurement and Transplant Network (OPTN) under Health Resources and Services Agency (HRSA) to evaluate outcomes…
- Trial name
- NCT07530991
- Where
- United States
- Volunteers
- 3,500 people
- Sponsor
- Chris Jaynes
Organ Transplant, Ischemic Reperfusion Injury
PERTRIAL - Perla® Preservation Solution
Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.
- Trial name
- NCT05194306
- Testing
- Perla® Cold Preservation solution
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Advanced Life Solutions
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
Delayed Graft Function, End Stage Renal Disease
Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
- Conditions
- Delayed Graft Function, End Stage Renal Disease, Deceased Donor Kidney Transplant
- Trial name
- NCT07020832
- Testing
- Pegcetacoplan
- Where
- Brazil
- Sponsor
- Apellis Pharmaceuticals, Inc.
Kidney Transplantation in Highly Sensitized Patients
Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts
An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) against a deceased donor prior…
- Trial name
- PAES (NCT05369975)
- Testing
- Imlifidase, Normal Transplantation Routine
- Where
- 22 sites in Austria, Belgium and 9 more
- Volunteers
- 113 people
- Sponsor
- Hansa Biopharma AB
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.
Renal Transplantation, Graft Rejection
A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection.
- Trial name
- NCT00089947
- Testing
- Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]
- Where
- 19 sites in United States
- Volunteers
- 150 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 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 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
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.
Kidney Transplantation
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)
The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients
- Trial name
- PERSPECTIVE (NCT04803058)
- Testing
- TCD601
- Where
- 3 sites in United States, South Korea
- Volunteers
- 7 people
- Sponsor
- ITB-Med LLC
Kidney Transplantation in Highly Sensitized Patients
Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys
The goal of this follow-up study is to learn about long-term patient survival and graft function in highly sensitized patients who have received desensitization treatment with imlifidase or standard of care (SoC) in order to…
- Trial name
- ConfIdeSLTFU (NCT05714514)
- Testing
- Imlifidase administered in the ConfIdeS study, Best available treatment administered in the ConfIdeS study
- Where
- 14 sites in United States
- Volunteers
- 64 people
- Sponsor
- Hansa Biopharma AB
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