Clinical trials: Graft Rejection
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
Kidney Transplant Rejection, End Stage Renal Disease
Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients
The purpose of this study is to evaluate the safety and tolerability of TX200-TR101 and its effects on the donated kidney in living donor kidney transplant recipients.
- Trial name
- STEADFAST (NCT04817774)
- Testing
- TX200-TR101
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Volunteers
- 26 people
- Sponsor
- Sangamo Therapeutics
Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
The objective of this trial is to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in single lung transplant recipients with…
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications
- Trial name
- BOSTON-1 (NCT03657342)
- Testing
- Liposomal Cyclosporine A, standard of care
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 62 people
- Sponsor
- Zambon SpA
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
Organ Transplant Rejection, Psoriasis
Safety and Pharmacokinetics of Sustained-release Depot Tacrolimus: A First-in-human Study
This first-in-human study is designed to assess the safety and pharmacokinetic (PK) profile of sustained-release (SR) depot tacrolimus, which will be administered as a single dose of 0.1 mg/kg by subcutaneous (SC) injection in…
- Trial name
- NCT03626714
- Testing
- Sustained Release Injectable Tacrolimus
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Auritec Pharmaceuticals
Corneal Endothelial Dystrophy, Corneal Edema
Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty…
- Trial name
- NCT05136443
- Testing
- loteprednol etabonate 0.25% ophthalmic suspension
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Price Vision Group
Fuchs' Dystrophy, Bullous Keratopathy
Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)
The purpose of this study is to compare two different commonly used steroid dosing regimens after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery.
- Trial name
- NCT01448213
- Testing
- Prednisolone acetate, Fluorometholone
- Where
- 2 sites in United States, Germany
- Volunteers
- 264 people
- Sponsor
- Price Vision Group
Renal Function, Liver Transplant
Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.
This study was designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.
- Trial name
- NCT01598987
- Testing
- Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.
- Where
- 32 sites in United States, Australia and 10 more
- Volunteers
- 56 people
- Sponsor
- Novartis Pharmaceuticals
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
Pharmacokinetics Study in de Novo Kidney Transplantation
Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal…
- Trial name
- Spartacus (NCT01649427)
- Testing
- Prograf, Tacrolimus Hexal
- Where
- 5 sites in Germany
- Volunteers
- 73 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Rejection
An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR
The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients.
- Trial name
- NCT04711850
- Testing
- Imlifidase
- Where
- 7 sites in Austria, France and 1 more
- Volunteers
- 18 people
- Sponsor
- Hansa Biopharma AB
Kidney Transplantation, Renal Transplantation
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in…
- Trial name
- ATHENA (NCT01843348)
- Testing
- Everolimus, Tacrolimus, Cyclosporin A
- Where
- 27 sites in France, Germany
- Volunteers
- 612 people
- Sponsor
- Novartis Pharmaceuticals
Transplant Rejection, Renal Transplantation
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China for prophylaxis of organ rejection in renal transplantation.
- Trial name
- NCT01236378
- Testing
- Sirolimus
- Where
- 2 sites in China
- Volunteers
- 24 people
- Sponsor
- Pfizer
Transplant Rejection
Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers
The purpose of this study is to determine the effects of belatacept on the pharmacokinetics of caffeine, losartan, omeprazole, dextromethorphan and midazolam
- Trial name
- NCT01766050
- Testing
- Caffeine, Losartan, Omeprazole
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Heart Transplantation
SCHEDULE Follow Up Visit 5-7 yr
The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary…
- Trial name
- CRAD001ANO05 (NCT02864706)
- Testing
- Everolimus, Cyclosporine, Mycophenolate mofetil
- Where
- 6 sites in Denmark, Norway and 1 more
- Volunteers
- 95 people
- Sponsor
- Novartis Pharmaceuticals
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
Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)
The objective of this trial was to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in double lung transplant (DLT) recipients…
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications
- Trial name
- BOSTON-2 (NCT03656926)
- Testing
- Liposomal Cyclosporine A, Standard of Care
- Where
- 40 sites in United States, Austria and 7 more
- Volunteers
- 169 people
- Sponsor
- Zambon SpA
Graft Rejection
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.
- Trial name
- NCT00300274
- Testing
- everolimus, mycophenolate mofetil, cyclosporine
- Where
- 64 sites in United States, Argentina and 13 more
- Volunteers
- 721 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerosis, Kidney Failure
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of…
- Trial name
- NCT00311311
- Testing
- tacrolimus, mycophenolate mofetil, prednisone
- Where
- 8 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Pfizer
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