CTRI/2012/02/002444尚未招募3 期
AN OPEN LABEL, RANDOMIZED, CONTROLLED MULTICENTRE STUDY TO ASSESS THE EFFICACY AND SAFETY OF MYCOPHENOLATE MR TABLETS* (PANACEA BIOTEC LTD) IN COMPARISON WITH MYFORTIC (NOVARTIS PHARMACEUTICALS CORPORATION) IN THE PROPHYLAXIS OF ACUTE REJECTION OF RENAL TRANSPLANTATION - Nil
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 204
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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