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Multicenter, Open-label Study to Assess Whether Treatment With Myfortic®(EC-MPS) Allows Higher Dose Optimization Versus Cellcept® (MMF) Leading to a Dose Reduction of Tacrolimus

2014-08-27 03:16:21 | BioPortfolio

Summary

The objective of the study is to demonstrate that Myfortic® allows higher dose optimization than MMF leading tacrolimus minimization in maintenance renal transplant patients

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Renal Transplant

Intervention

Mycophenolate sodium, Mycophenolate mofetil

Location

Novartis Investigative Site Barcelona
Barcelona
Spain

Status

Not yet recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:21-0400

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Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

The purpose of this study is to evaluate the safety and the tolerability of the substitution of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable rena...

Enteric-Coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With GI Intolerance

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolera...

Study of Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients

Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incid...

Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation

This open, multi-center randomized controlled study is designed to investigate the quality of life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse events...

Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil

This study will access the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will ...

PubMed Articles [5387 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetics Evaluation of Mycophenolic Acid and its Glucuronide Metabolite in Chinese Renal Transplant Recipients Receiving Enteric-coated Mycophenolate Sodium and Tacrolimus.

The aim of this study was to characterize the pharmacokinetics of mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) in Chinese renal transplant patients taking enteric-coated mycophenol...

Mycophenolate mofetil for induction and maintenance of remission in naïve patients with granulomatosis with polyangiitis without renal involvement.

Antineutrophil cytoplasmic antibodies (ANCA) associated vasculitides include granulomatosis with polyangiitis (GPA, previously called Wegener's), microscopic polyangiitis (MPA) and eosinophilic granul...

Combination therapy with rituximab and mycophenolate mofetil in systemic sclerosis. A single-centre case series study.

To describe a single centre experience using combination therapy with rituximab (RTX) and mycophenolate mofetil (MMF) in a prospective series of systemic sclerosis (SSc) patients with pulmonary and cu...

CXCR4 Antagonist Reduced the Incidence of Acute Rejection and Controlled Cardiac Allograft Vasculopathy in a Swine Heart Transplant Model Receiving a Mycophenolate-Based Immunosuppressive Regimen.

CXCR4 blockade is pursued as an alternative to mesenchymal stem cell (MSC) treatment in transplantation based on our previous report that burixafor, through CXCR4 antagonism, mobilizes immunomodulator...

Development of an Abbreviatted Mycophenolic Acid Area-Under-The-Time Concentration Curve for Renal Transplanted Patients under Enteric-Coated Mycophenolate Sodium: A Comparison with Critical Analysis of Available Equations.

Enteric-coated mycophenolate sodium (EC-MPS) is frequently used in renal transplantation. The pharmacokinetic profile of mycophenolic acid (MPA) shows a broad range of time-to-maximum-concentration (T...

Medical and Biotech [MESH] Definitions

A non-electrogenic sodium-dependent phosphate transporter. It is found primarily in apical membranes of PROXIMAL RENAL TUBULES.

An electrogenic sodium-dependent phosphate transporter. It is present primarily in BRUSH BORDER membranes of PROXIMAL RENAL TUBULES.

Functional KIDNEY FAILURE in patients with liver disease, usually LIVER CIRRHOSIS or portal hypertension (HYPERTENSION, PORTAL), and in the absence of intrinsic renal disease or kidney abnormality. It is characterized by intense renal vasculature constriction, reduced renal blood flow, OLIGURIA, and sodium retention.

A heterogeneous group of disorders characterized by renal electrolyte transport dysfunctions. Congenital forms are rare autosomal disorders characterized by neonatal hypertension, HYPERKALEMIA, increased RENIN activity and ALDOSTERONE concentration. The Type I features HYPERKALEMIA with sodium wasting; Type II, HYPERKALEMIA without sodium wasting. Pseudohypoaldosteronism can be the result of a defective renal electrolyte transport protein or acquired after KIDNEY TRANSPLANTATION.

An autosomal inherited disorder due to defective reabsorption of GLUCOSE by the PROXIMAL RENAL TUBULES. The urinary loss of glucose can reach beyond 50 g/day. It is attributed to the mutations in the SODIUM-GLUCOSE TRANSPORTER 2 encoded by the SLC5A2 gene.

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