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Follow-up Study of Safety of Enteric-Coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301

2014-08-27 03:51:42 | BioPortfolio

Summary

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 survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Renal Transplant

Intervention

Mycophenolate sodium (enteric coated)

Status

Active, not recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:51:42-0400

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Follow-up Study of Safety of Enteric-Coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302

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PubMed Articles [6462 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...

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...

Fibroblast growth factor 23 is associated with fractional excretion of sodium in patients with chronic kidney disease.

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Medical and Biotech [MESH] Definitions

Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)

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.

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