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MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive

Año 2004
Autores Novartis
Registro de estudios clinicaltrials.gov
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To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.

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3 months interim results of a 12-month study with enteric-coated mycophenolate sodium (ECMPS, Myfortic®), basiliximab, and neoral C-2 comparing different steroid protocols in de novo kidney recipients

Año 2005
Autores Vincenti F , Schena F , Walker R , et al
Revista JAmSoc Nephrol
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Estudio primario

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12-month results of a prospective, randomised trial of steroid avoidance, steroid withdrawal and standard steroids in de novo renal transplant patients receiving cyclosporine, enteric-coated mycophenolate sodium (EC-MPS) and basiliximab

Año 2006
Revista Am J Transplant
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Estudio primario

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Metabolic effects of steroid avoidance or early steroid withdrawal: 12-month results of a randomized trial in de novo renal transplant patients receiving cyclosporine enteric-coated mycophenolate sodium (EC-MPS) and basiliximab

Año 2006
Revista Am J Transplant
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Estudio primario

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A Multicenter, Open-label, Randomized, Two Arm Study to Investigate the Efficacy and Safety of a Therapy Avoiding Intraoperative Steroids in Combination With Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients

Año 2016
Autores Novartis Pharma GmbH
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Estudio primario

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In kidney transplant patients, alemtuzumab but not basiliximab/low-dose rabbit anti-thymocyte globulin induces B cell depletion and regeneration, which associates with a high incidence of de novo donor-specific anti-HLA antibody development.

Año 2013
Revista Journal of immunology (Baltimore, Md. : 1950)
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In this single-center matched-cohort study, we evaluated the phenotype of repopulating B cells and its correlation with donor-specific anti-HLA Ab development and long-term graft function in 16 renal transplant recipients and 32 age- and gender-matched controls induced with alemtuzumab or basiliximab (Bas)/low-dose rabbit anti-thymocyte globulin (rATG), respectively. Alemtuzumab, but not Bas/rATG, profoundly depleted peripheral B cells in the first 2 mo posttransplantation. Early posttransplant, naive B cells were significantly depleted, whereas Ag-experienced and memory B cells were partially spared. Transitional B cells transiently increased 2 mo posttransplant. At month 6 posttransplant, pregerminal center B cells emerged, a process promoted by increased BAFF serum levels. Thereafter, B cell counts increased progressively, mainly due to expansion of naive B cells. Conversely, Bas/rATG did not modify the B cell phenotype throughout the follow-up period. Alemtuzumab was associated with a higher incidence of de novo DSA compared with Bas/rATG. DSA development was predicted by changes in the B cell compartment and correlated with worse long-term graft function. Thus, alemtuzumab-induced B cell depletion/reconstitution may promote chronic humoral responses against the graft.

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Prévention chez le receveur avec néphropathie à IgA primaire (NIGA) de la Récidive Après Transplantation rénale: ATG-F versus Basiliximab, comme traitements immunosuppresseurs d’induction. Etude PIRAT: a vs B - PIRAT

Año 2010
Autores [No se listan los autores]
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INTERVENTION:

Trade Name: GLOBULINES ANTILYMPHOCYTAIRES FRESENIUS Pharmaceutical Form: Solution for infusion Trade Name: SIMULECT Pharmaceutical Form: Powder and solvent for solution for injection

CONDITION:

IgA glomerulonephritis and first transplant ; MedDRA version: 12.1 Level: LLT Classification code 10018367 Term: Glomerulonephritis chronic ; MedDRA version: 12.1 Level: LLT Classification code 10023438 Term: Kidney transplant

PRIMARY OUTCOME:

Main Objective: Demonstration of a protective effect of ATG‐Fresenius against the clinical and histological recurrence of IgA nephropathy after primary first kidney transplant and compared to simulect Primary end point(s): Clinico‐histological recurrence of IgA in monitoring a first transplant Secondary Objective: For the efficacy, Comparison in the 2 groups :; ‐ histological recurrence confirmed by renal biopsy at 5 years ; ‐ graft loss ; ‐ quality of graft function at 5 years ; ‐ cumulative incidence of acute rejection and / or chronic rejection proved by renal biopsy to 5 years ; ‐ onset of hypertension; ‐ survival of grafts and patients up to 5 years ; For the safety, comparison in the 2 goups :; ‐ infection and CMV disease at 1 year ; ‐ other microbial infections at 1 year post‐transplant. ; ‐ incidence of cancers up to 5 years with 3 topics: skin cancer, cancers of organs (solid) and lymphomas. ;

INCLUSION CRITERIA:

‐ Patient aged = 18 and <75 years ‐ Free, informed, express and written. ‐ Diagnosis of native kidney primary IgA glomerulonephritis biopsy‐proven ‐ First kidney transplantation (one kidney) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

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A MULTICENTER, THREE ARM, RANDOMIZED, OPEN LABEL CLINICAL STUDY TO COMPARE RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS RECEIVING AN IMMUNOSUPPRESSIVE REGIMEN OF ADVAGRAF® (IMMEDIATELY OR DELAYED POST-TRANSPLANT) AND MMF WITH OR WITHOUT A MONOCLONAL ANTI-IL2R ANTIBODY (BASILIXIMAB)

Año 2010
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: Advagraf Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

TACROLIMUS CAS Number: 104987113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ Trade Name: Advagraf Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

TACROLIMUS CAS Number: 104987113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0‐ Trade Name: Advagraf Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

TACROLIMUS CAS Number: 104987113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.0‐ Trade Name: Simulect Pharmaceutical Form: Powder and solvent for solution for injection Other descriptive name: BASILIXIMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐

CONDITION:

RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS RECEIVING AN IMMUNOSUPPRESSIVE REGIMEN OF ADVAGRAF® (IMMEDIATELY OR DELAYED POST‐TRANSPLANT) AND MMF WITH OR WITHOUT SIMULECT ; MedDRA version: 9.1 Level: LLT Classification code 10024716 Term: Liver transplantation

PRIMARY OUTCOME:

Main Objective: The primary objective of this study is to compare the three therapy regimens with regard to renal function. Primary end point(s): Renal function assessed by eGFR (MDRD4 formula: estimates GFR using four variables: serum creatinine, age, race, and gender) at 24 weeks after transplantation is the primary endpoint of the study. Secondary Objective: The secondary objective is to compare the safety and efficacy profiles of the three therapy regimens with each other.

INCLUSION CRITERIA:

A subject is eligible for the study if all of the following apply: 1. Age = 18 years. 2. Undergoing orthotopic liver or split liver allograft transplantation. 3. Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study and during 6 weeks after cellcept is stopped 4. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent has been obtained). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

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A 12 month, multicenter, randomized, parallel, open-label study, to evaluate renal function and efficacy of Certican® (everolimus) with Simulect® (basiliximab) and cyclosporine discontinuation at 3 month post-transplant vs minimization, in de novo kidney transplant recipients

Año 2006
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Trade Name: Certican® Product Name: Certican® Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed

INN:

EVEROLIMUS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.50‐ Trade Name: Certican® Product Name: Certican® Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed

INN:

EVEROLIMUS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.75‐

CONDITION:

Renal Transplant ; MedDRA version: M15 Classification code 10023438

PRIMARY OUTCOME:

Main Objective: The primary objective is to compare renal function in the two treatment groups at month 12 post‐transplant, as measured by calculated GFR (Nankivell), serum creatinine and calculated creatinine clearance (Cockroft‐ Gault).; Intra‐group change in GFR , as determined by Nankivell’s formula, and the GFR’s slope in the period between visits 6 and 12 months will also be determined.; Primary end point(s): The GFR value is calculated using the Nankivell formula. This is the end point in witch sample size is based. Secondary Objective: The secondary objectives of this study are:; • To evaluate the incidence of biopsy‐proven acute rejection (BPAR) episodes, graft loss, death or loss to follow‐up after 12 months in both groups.; • To evaluate the incidence of graft loss, death, BPAR episodes, antibody treated acute rejection episodes, clinically confirmed acute rejection episodes, clinically confirmed chronic rejection episodes and biopsy‐proven chronic allograft nephropathy after 12 months in both groups.; • To evaluate the safety of Certican® in combination with Simulect® and steroids, with either Neoral® discontinuation at 3 months post‐transplant, or Neoral® minimization.;

INCLUSION CRITERIA:

Each patient must meet all of the following

INCLUSION CRITERIA:

1. Male or female patients between 18 and 65 years of age 2. Male or female patients who are recipients of a first renal transplant from a primary cadaveric or non‐HLA identical living related donor . 3. The renal cold ischemic time (CIT) must be < 36 hours 4. The age of the donor must be < 65 years 5. Females of childbearing potential must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication. 6. Patients who have given written informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

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A one‐year, randomised, open label, parallel group study to investigate the safety and efficacy of enteric‐coated mycophenolate sodium (EC‐MPS) in combination with full dose or reduced dose cyclosporine microemulsion (CSA‐ME), basiliximab and steroids in de novo kidney transplantation

Año 2006
Autores Chadban S , Campbell S , Russ G , Walker R , Chapman J , Pussell B - Más
Revista Transplantation Society of Australia & New Zealand (TSANZ)
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