Health Condition 1: null- De Novo Renal Transplant patients. End Stage kidney disease patients
Conditions
Interventions
Intervention1: ERL080 (EC-MPS- Enteric Coated Mycophenolate Soduim): 320 milligram twice daily or 720 milligram twice daily. Oral. Total duration of study will be 2 years and 3 months till June 2013.
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female de novo renal transplant recipients between 18 and 70 years of age. 2. Patients who are receiving a primary cadaveric donor or non-HLA identical living donor kidney transplant (liver related haplograft). 3. Patients who have given written informed consent to participate in the study. 4. Females capable of becoming pregnant must have a negative pregnancy test prior to randomization and willing to use an effective means of contraception for the total study duration.
Exclusion criteria
Exclusion criteria: 1. Patients who are recipients of multiple solid organ or tissue transplants (dual kidney is allowed), or have previously received an organ or tissue transplant. 2. Patients who are recipients of ABO incompatible transplants or T cell cross match positive transplant. 3. Patients with platelet count 100,000/mm at the evaluation before randomization. 4. Patients with an absolute neutrophil count of 1,500/mm³ at baseline before surgery or white blood cell count of 4,500/mm³, or leukocytopenia ( 2,500/mm3), or hemoglobin 6g/dL prior to randomization. 5. Renal cold ischemic time (CIT) 30 hours. 6. Patients with a known hypersensitivity to either study drugs or their class, or to any of excipients 7. Patients with clinically significant systemic infection at time of transplant or within two weeks of transplant. 8. Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter absorption, distribution, metabolism and excretion of study medication. 9. Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (-HCG) at Screen. 10. Patient is of childbearing potential (men and women) and unwilling to use a barrier method of contraception. It is required that a barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients of childbearing potential (men and women) regardless of whether a hormonal agent also is used as a method of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of equimolar Enteric coated Mycophenolate Sodium (EC-MPS) versus Mycophenolate Mofetil (MMF) with reduced levels of tacrolimus, in de novo renal transplant recipients in terms of : # Calculated Glomerular Filtration rate # Serum creatinine change (%) # Composite efficacy failure rate (BPAR, graft loss, death)Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate graft and patient survival for equimolar Enteric coated Mycophenolate Sodium (EC-MPS) versus Mycophenolate Mofetil (MMF) with reduced levels of tacrolimus, in de novo renal transplant recipients at 12 months post-transplant.Timepoint: 12 months;2. To evaluate the cumulative number (incidence) and severity of biopsy proven acute rejections (BPAR) for equimolar Enteric coated Mycophenolate Sodium (EC-MPS) versus Mycophenolate Mofetil (MMF) with reduced levels of tacrolimus, in de novo renal transplant recipients at month 12 post-transplant (Biopsy optional)Timepoint: 12 months;3. To evaluate changes in cardiovascular risk factors (blood pressure, blood sugar, lipid profile) for equimolar Enteric coated Mycophenolate Sodium (EC-MPS) versus Mycophenolate Mofetil (MMF) with reduced levels of tacrolimus, in de novo renal transplant recipients at 12 months post-transplant.Timepoint: 12 months;4. To evaluate the safety and tolerability with the immunosuppressive regimen in terms of: # Adverse events (e.g. Gastrointestinal side effects, Incidence of hypertension, anti-hypertensive medication, hyperlipidemia, diabetes mellitus, anemia, leukopenia, thrombocytopenia, malignant disease, infections, etc) # Laboratory variables [Complete blood counts, Glucose control (FBG), Lipid profile ? cholesterol, HDL-cholesterol and triglyceride.]Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Sameer Guliani
Novartis
Outcome results
None listed