Health Condition 1: N186- End stage renal disease
Conditions
Interventions
Intervention1: De novo renal transplant recipients receiving MMF 1 g BD: The AUC shall be determined and correlated with the occurence of GI adverse events
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients above 18 years of age of either sex 2. Patients who have undergone 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
Exclusion criteria
Exclusion criteria: 1. Patients undergoing multi-organ transplantation 2. Patients harbouring HIV, Hepatitis B or C infections 3. Patients suffering from any malignancy requiring recent surgery, ongoing chemotherapy or radiation 4. Patients suffering from any acute systemic infections within 30 days prior to enrolment 5. Patients who had received any investigational drug within past 6 months 6. Pregnant, nursing mothers or women of childbearing potential without an effective method of birth control 7. Patients who are started on enteric coated mycophenolate sodium (EC-MPS) 8. Patients not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine whether there is any correlation between AUC of MMF and the incidence of drug-related GI adverse events in the first six months post-transplantTimepoint: 1. To determine whether there is any correlation between AUC of MMF and the incidence of drug-related GI adverse events in the first six months post-transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine whether there is any correlation between AUC of MMF and the severity of GI adverse events on the gastrointestinal symptom rating scale (GSRS)Timepoint: First six months after de novo renal transplantation | — |
Countries
India
Contacts
Public ContactDR SMITA PATTANAIK
PGIMER, CHANDIGARH
Outcome results
None listed