Clinical Trial: The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis
Brief Summary: To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.
Detailed Summary:
In this study, there are two sub-studies in order to define secondary endpoints.
- Pharmacokinetics study of Mycophenolic acid
- Identify biomarkers for therapy-resistant prediction.
- Identify biomarkers for predicting a loss of kidney function.
Sponsor: Chulalongkorn University
Current Primary Outcome: Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment [ Time Frame: 12 months ]
- The ratio of patients with declined renal function [ Time Frame: 12 months ]
- Time to remission [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Chulalongkorn University
Dates:
Date Received: November 17, 2009
Date Started: January 2010
Date Completion:
Last Updated: October 9, 2014
Last Verified: October 2014
