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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 also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS).
Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Maintenance Kidney Transplant
Enteric-coated Mycophenolate sodium (EC-MPS), Mycophenolate mofetil
Published on BioPortfolio: 2014-08-27T03:41:33-0400
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...
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...
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...
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...
Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft surviv...
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...
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...
To develop an oral sustained release formulation of mycophenolate mofetil (MMF) for once-daily dosing, using chitosan-coated polylactic acid (PLA) or poly(lactic-co-glycolic) acid (PLGA) nanoparticles...
Antineutrophil cytoplasmic antibodies (ANCA) associated vasculitides include granulomatosis with polyangiitis (GPA, previously called Wegener's), microscopic polyangiitis (MPA) and eosinophilic granul...
The transplant community is divided regarding whether substitution with generic immunosuppressants is appropriate for organ transplant recipients. We estimated the rate of uptake over time of generic ...
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
The sodium salt of 4-hydroxybutyric acid. Anesthetic used for both induction and maintenance. It may cause bradycardia and dyskinesias.
Fluorescent antibody technique for visualizing antibody-bacteria complexes in urine. The presence or absence of antibody-coated bacteria in urine correlates with localization of urinary tract infection in the kidney or bladder, respectively.
An element that is a member of the alkali group of metals. It has the atomic symbol Na, atomic number 11, and atomic weight 23. With a valence of 1, it has a strong affinity for oxygen and other nonmetallic elements. Sodium provides the chief cation of the extracellular body fluids. Its salts are the most widely used in medicine. (From Dorland, 27th ed) Physiologically the sodium ion plays a major role in blood pressure regulation, maintenance of fluid volume, and electrolyte balance.
A sodium-hydrogen antiporter expressed primarily by EPITHELIAL CELLS in the kidneys, it localizes to the apical membrane of the PROXIMAL KIDNEY TUBULE, where it functions in sodium and water reabsorption and possibly calcium homeostasis. It also is expressed in heart, brain, and lung tissues and is resistant to AMILORIDE inhibition.
Chronic kidney disease (CKD), also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. The symptoms of worsening kidney function are non-specific, and might include feeling generally unwell and experi...
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...