Clinical trials: Allograft Rejection
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
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 Failure
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly…
- Trial name
- LCPTacro3002 (NCT01187953)
- Testing
- Prograf (tacrolimus), LCP-Tacro
- Where
- 86 sites in United States, Argentina and 13 more
- Volunteers
- 543 people
- Sponsor
- Veloxis Pharmaceuticals
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 Transplantation
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection.
- Trial name
- NCT00263328
- Testing
- Tacrolimus, CP-690,550
- Where
- 27 sites in United States
- Volunteers
- 46 people
- Sponsor
- Pfizer
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
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
Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis
EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
The purpose of this study is to assess the efficacy and safety of the study drug, known as "ATG Fresenius S," which is sometimes called "EZ-2053," to prevent a lung transplant patient's body from rejecting a transplanted lung or…
- Conditions
- Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, Bronchiectasis
- Trial name
- NCT00105183
- Testing
- EZ-2053, EZ-2053 5mg/kg
- Where
- 19 sites in United States, Australia and 2 more
- Volunteers
- 223 people
- Sponsor
- Neovii Biotech
Renal Failure
Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules…
- Trial name
- NCT00817206
- Testing
- LCP-Tacro, Prograf
- Where
- United States
- Volunteers
- 326 people
- Sponsor
- Veloxis Pharmaceuticals
Transplantation, Organ
A Study of Belimumab in the Prevention of Kidney Transplant Rejection
Kidney transplantation is the best treatment for many patients with kidney failure. Sometimes a transplanted kidney is rejected by the patient's immune system.
- Trial name
- NCT01536379
- Testing
- Belimumab
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
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
Graft Rejection, Kidney Transplant
Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.
- Conditions
- Graft Rejection, Kidney Transplant, Renal Allograft Recipients, Renal Transplant
- Trial name
- NCT00895583
- Testing
- Tacrolimus, Sirolimus
- Where
- 44 sites in United States, Argentina and 5 more
- Volunteers
- 254 people
- Sponsor
- Pfizer
Kidney Transplantation
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients…
- Trial name
- NCT00658359
- Testing
- Cyclosporine, CP-690,550
- Where
- 65 sites in United States, Australia and 13 more
- Volunteers
- 178 people
- Sponsor
- 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
Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft
Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate Sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate Mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.
Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.
- Trial name
- MAXIMIZA (NCT01056822)
- Testing
- 1, 2
- Where
- 19 sites in Spain
- Volunteers
- 89 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection.
- Trial name
- NCT00483756
- Testing
- Cyclosporine, CP-690,550
- Where
- 69 sites in United States, Australia and 13 more
- Volunteers
- 338 people
- Sponsor
- Pfizer
Renal Failure
Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
- Trial name
- NCT01666951
- Testing
- LCP-Tacro tablets, Prograf
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- Veloxis Pharmaceuticals
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
Chronic Allograft Nephropathy, Chronic Kidney Disease
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck.
- Conditions
- Chronic Allograft Nephropathy, Chronic Kidney Disease, Chronic Renal Failure, Disordered Mineral Metabolism
- Trial name
- NCT00975000
- Testing
- Cinacalcet
- Where
- 51 sites in United States, Australia and 9 more
- Volunteers
- 114 people
- Sponsor
- Amgen
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