Health Condition 1: N186- End stage renal disease
Conditions
Interventions
Intervention1: Therapeutic drug monitoring for Mycophenolate Mofetil: Doses of MMF shall be adjusted based on the plasma drug levels
Control Intervention1: Conventional monitoring for Mycophenolate Mo
Sponsors
Investigator initiated trial
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the difference between AUC controlled-dose adjustment and clinical judgement based-dose adjustment of MMF in the first six months after de novo renal transplantation in terms of 1. incidence of biopsy proven acute graft rejection 2. incidence of gastrointestinal adverse events 3. overall treatment expenditure 4. quality of life on the EQ-5D-5L questionnaire Timepoint: First six months after renal transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To determine any association between AUC of MMF and the biopsy proven acute graft rejection in the first 6 months after de novo renal transplantation 2.To determine any association between AUC of MMF and the incidence of gastrointestinal adverse effects in the first 6 months after de novo renal transplantation 3. To determine the difference between AUC controlled-dose adjustment and clinical judgement based-dose adjustment in terms of severity of gastrointestinal adverse events Timepoint: First six months after de novo renal transplantation | — |
Countries
India
Contacts
Public ContactDr Bhaskar Krishnamurthy
PGIMER, Chandigarh
Outcome results
None listed