AUC-Controlled Mycophenolate Mofetil (MMF) Dosing v/s Conventional MMF Dosing: A Clinical Efficacy, Safety and Pharmacoeconomic Study

Investigator initiated trial0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patients who have undergone a de novo renal transplantation in the past two weeks (15 days) and have been started on MMF (CELLCEPT) at a dose of 1 g twice a day
•2. Patients who have attained a steady state level of tacrolimus (10-15 ng/mL)

•1.Patients who are started on enteric coated mycophenolate sodium (EC-MPS)
•2.Patients who have previously undergone renal transplantation or any other solid organ transplantation
•3.Patients suffering from infections such as HIV, Hepatitis B, Hepatitis C
•4.Patients who are presently diagnosed to be suffering from any malignancy
•5.Patients who are presently abusing of any narcotic or psychotropic drugs (marijuana, cocaine, opioids, amphetamines, barbiturates, benzodiazepines)
•6.Patients found to have any gross abnormality in the general laboratory investigations at the time of screening
•7.Patients with any chronic severe illness that is likely to jeopardize the conduct of study or interpretation of results, such as severe liver failure (MELD score >=30); severe heart failure (NYHA class IV) and severe chronic obstructive pulmonary disease (GOLD stage IV)
•8.Women who are currently pregnant or nursing women or women who are in the reproductive age group and do not wish to use any method of contraception
•9.Patients who have participated in any clinical trial or have received any investigational new drug in the past 6 months
•10.Patients not willing to participate in the study

发起方

Investigator initiated trial