NCT01015456

The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis

The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

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 description

In this study, there are two sub-studies in order to define secondary endpoints. 1. Pharmacokinetics study of Mycophenolic acid 2. Identify biomarkers for therapy-resistant prediction. 3. Identify biomarkers for predicting a loss of kidney function.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	mycophenolate sodium	per oral, twice daily, for 12 months
DRUG	cyclophosphamide	intravenous, monthly, for 6 months

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-11-18
• Last updated: 2014-10-10

Locations

3 sites across 1 country: Thailand