Clinical trials: Rejection of Renal Transplant
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 de Novo Transplant
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
- Trial name
- NCT00238992
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 144 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant.
- Trial name
- NCT00118742
- Testing
- mycophenolate mofetil [CellCept], Tacrolimus, Cyclosporine
- Where
- 46 sites in United States, Canada
- Volunteers
- 293 people
- Sponsor
- Hoffmann-La Roche
Antibody-mediated Rejection
Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
- Trial name
- NCT03221842
- Testing
- C1-esterase inhibitor
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 63 people
- Sponsor
- CSL Behring
Pediatric Kidney Transplantation
Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to…
- Trial name
- NCT00228020
- Testing
- basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent), MMF, cyclosporine, steroids
- Volunteers
- 212 people
- Sponsor
- Novartis
Graft Rejection, Kidney Transplantation
Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney
The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better…
- Conditions
- Graft Rejection, Kidney Transplantation, Renal Transplantation
- Trial name
- NCT00035555
- Testing
- Belatacept, Cyclosporine, Mycophenolate mofetil (MMF)
- Where
- 12 sites in United States
- Volunteers
- 230 people
- Sponsor
- Bristol-Myers Squibb
Graft Rejection
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
- Trial name
- NCT01147302
- Testing
- C1 Esterase Inhibitor (Human)
- Where
- 5 sites in United States, Germany
- Volunteers
- 18 people
- Sponsor
- Shire
Liver Transplant
A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC…
- Trial name
- REDUCE (NCT02040584)
- Testing
- Minimisation of TAC, TAC + MMF + corticosteroids
- Where
- 20 sites in Spain
- Volunteers
- 217 people
- Sponsor
- Novartis Pharmaceuticals
Graft Rejection, Kidney Failure
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction…
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplantation
- Trial name
- NCT00261820
- Testing
- tacrolimus, mycophenolate mofetil, methylprednisolone
- Volunteers
- 160 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplantation
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection…
- Trial name
- NCT00885820
- Testing
- Tacrolimus, MMF, Corticosteroids (Prednisone)
- Where
- 12 sites in United States, Canada
- Volunteers
- 240 people
- Sponsor
- Astellas Pharma Inc
Graft Rejection, Kidney Transplantation
A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure
- Trial name
- CRAF (NCT00510913)
- Testing
- tacrolimus
- Where
- 18 sites in United States
- Volunteers
- 450 people
- Sponsor
- Astellas Pharma Inc
Kidney Failure, Graft Rejection
Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.
- Conditions
- Kidney Failure, Graft Rejection, Aged
- Trial name
- NCT00254709
- Testing
- Sirolimus
- Volunteers
- 66 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplantation
A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and…
- Trial name
- NCT00106639
- Testing
- CP-690,550, tacrolimus
- Where
- 20 sites in United States
- Volunteers
- 61 people
- Sponsor
- Pfizer
Antibody-mediated Rejection in Kidney Transplant
Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection
This study investigates the burden of disease among kidney transplant recipients that have developed Chronic Active Antibody Mediated Rejection (caAMR) compared with kidney transplant recipients that have not developed caAMR
- Trial name
- NCT05452317
- Testing
- Chronic active AMR group, Non-Chronic active AMR group
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- CSL Behring
Kidney Transplantation
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
- Trial name
- CIRRUS I (NCT03663335)
- Testing
- CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), Corticosteroids (CS)
- Where
- 74 sites in United States, Argentina and 18 more
- Volunteers
- 418 people
- Sponsor
- Novartis Pharmaceuticals
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 Transplantation
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
The safety and efficacy of FTY720 is being evaluated in patients who receive a kidney transplant.
- Trial name
- NCT00099801
- Testing
- FTY720
- Sponsor
- Novartis Pharmaceuticals
Kidney Diseases, Kidney Injury
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and/or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney…
- Conditions
- Kidney Diseases, Kidney Injury, BK Virus Infection, CMV
- Trial name
- ID-ENTITY (NCT07393594)
- Testing
- Blood tests, TRAC( cell free DNA) and T-ID
- Where
- 14 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Transplant Genomics, Inc.
Renal Transplant Rejection
Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept®…
- Trial name
- IBERICA (NCT01324934)
- Testing
- ATG-Fresenius S
- Where
- 10 sites in Portugal, Spain
- Volunteers
- 40 people
- Sponsor
- Neovii Biotech
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