A clinical trial to assess the efficacy and safety of mycophenolate modified release tablets in the prophylaxis of acute rejection of renal transplantatio
- Conditions
- Health Condition 1: null- Patients with renal transplantation
- Registration Number
- CTRI/2012/02/002444
- Lead Sponsor
- Panacea Biotec Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 204
1.Patients of either sex, 18-75years
2.Patients having at least 40 Kg of body weight
3.Patients receiving their first kidney transplant
4.Patients willing to give informed consent
5.Patients able to take oral medications
6.Patients having negative T-cell cross match
1.Pregnant women and lactating women
2.Women who do not agree to use adequate method for contraception
3.Recipient of paediatric enbloc kidney
4.WBC count of 2,500 cells/mm3, platelet count 1000X 103 cells/mm3 or Hb 6 g%
5.Patients who have receiveda multi-organ transplant
6.Systemic infections requiring continued antibiotic therapy
7.Patients with active liver disease, HBsAg, HCV or HIV positive patients
8.Patients with known hypersensitivity to mycophenolate or any components of the formulation, cyclosporine or steroids
9.Malignancy or history of malignancy other than adequately treated skin carcinoma
10.Patients receiving investigational prophylactic immunosuppressants
11.Patients with active ulcer disease, severe diarrhoea, or any other GI disorder that might interfere with the absorption of medications
12.Patients who do not fully understand the purpose of the study or were already involved in other studies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate that the prevention of acute renal graft rejection episodes with Mycophenolate MR Tablets (Panacea Biotec Ltd) when administered once daily is non inferior to Myfortic (Novartis Pharmaceuticals Corporation) when administered twice daily at the end of 12 weeks of study treatmentTimepoint: 12 weeks of study treatment
- Secondary Outcome Measures
Name Time Method To evaluate that the Renal Graft Function with Mycophenolate MR Tablets (Panacea Biotec Ltd) when administered once daily is non-inferior to Myfortic (Novartis Pharmaceuticals Corporation) when administered twice daily <br/ ><br>To evaluate that Safety (Incidences of clinical and Laboratory AEs) with Mycophenolate MR Tablets (Panacea Biotec Ltd) when administered once daily is non-inferior to Myfortic (Novartis Pharmaceuticals Corporation) when administered twice dailyTimepoint: 12 weeks of study treatment