Clinical Trial: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Brief Summary: This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.

Detailed Summary: This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day & 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.
Sponsor: Genovate Biotechnology Co., Ltd.,

Current Primary Outcome:

  • Change in serum albumin [ Time Frame: 24 weeks treatment ]
  • Change in serum creatinine [ Time Frame: 24 weeks treatment ]
  • Change in spot urine protein/creatinine ratio [ Time Frame: 24 weeks treatment ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in serum albumin [ Time Frame: 12 weeks treatment ]
  • Change in serum creatinine [ Time Frame: 12 weeks treatment ]
  • Change in spot urine protein/creatinine ratio [ Time Frame: 12 weeks treatment ]
  • Change in cholesterol [ Time Frame: 24 weeks treatment ]
  • Change in triglyceride [ Time Frame: 24 weeks treatment ]
  • Change in complete blood count/differential count (CBC/DC) [ Time Frame: 24 weeks treatment ]
  • Change in number of subjects with doubling of serum creatinine [ Time Frame: 24 weeks treatment ]
  • Change in the average daily dose of oral prednisolone [ Time Frame: 24 weeks treatment ]


Original Secondary Outcome: Same as current

Information By: Genovate Biotechnology Co., Ltd.,

Dates:
Date Received: October 25, 2016
Date Started: July 2015
Date Completion:
Last Updated: March 1, 2017
Last Verified: March 2017