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Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients

2014-08-27 03:46:24 | BioPortfolio

Summary

This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Kidney Diseases

Intervention

Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus, EC-MPS, Tacrolimus, Corticosteroids

Location

Novartis
Basel
Switzerland

Status

Completed

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:46:24-0400

Clinical Trials [2718 Associated Clinical Trials listed on BioPortfolio]

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

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...

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

Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serio...

A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.

This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be...

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...

Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as...

PubMed Articles [5873 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...

Impact of POR and CYP3A5 Polymorphisms on Trough Concentration to Dose Ratio of Tacrolimus in the Early Post-Operative Period Following Kidney Transplantation.

Tacrolimus, a critical dose drug, is widely used in transplantation. Knowing the contribution of genetic factors, which significantly influence tacrolimus variability, is beneficial in the personaliza...

Determination of Tacrolimus Concentration and Protein Expression of P-Glycoprotein in Single Human Renal Core Biopsies.

Tacrolimus is currently the cornerstone of immunosuppressive protocols for renal transplant recipients. Despite therapeutic whole blood monitoring, tacrolimus is associated with nephrotoxicity and it ...

Extended release versus immediate release tacrolimus in kidney transplant recipients: a systematic review and meta-analysis.

To compare the estimated glomerular filtration rate (eGFR) at 12 months together with other outcomes among adult kidney transplant recipients (KTRs) who received extended release, once daily tacrolim...

Evaluation of tacrolimus-related CYP3A5 genotyping in China: Results from the First External Quality Assessment Exercise.

Tacrolimus is the most widely used immunosuppressant in solid organ transplant patients. The cytochrome P450 3A5 (CYP3A5) has been proved to be associated with tacrolimus dose requirement. Molecular d...

Medical and Biotech [MESH] Definitions

A 12-KDa tacrolimus binding protein that is found associated with and may modulate the function of calcium release channels. It is a peptidyl-prolyl cis/trans isomerase which is inhibited by both tacrolimus (commonly called FK506) and SIROLIMUS.

A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-

A serine threonine kinase that controls a wide range of growth-related cellular processes. The protein is referred to as the target of RAPAMYCIN due to the discovery that TACROLIMUS (commonly known as rapamycin) forms an inhibitory complex with TACROLIMUS BINDING PROTEIN 1A that blocks the action of its enzymatic activity.

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

A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.

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