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

Phase 3 Terminated 59 enrolled Chulalongkorn University Clinical Research Collaborative Network · collab Health Intervention and Technology Assessment Program (HITAP) · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2010-01
Primary completion: 2013-01
Completion: 2013-01

Publications

Anutrakulchai S, Panaput T, Wongchinsri J, Chaishayanon S, Satirapoj B, Traitanon O, Pima W, Rukrung C, Thinkhamrop B, Avihingsanon Y. A multicentre, randomised controlled study of enteric-coated mycophenolate sodium for the treatment of relapsed or resistant proliferative lupus nephritis: an Asian experience. Lupus Sci Med. 2016 Jan 14;3(1):e000120. doi: 10.1136/lupus-2015-000120. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Comparator	Cyclophosphamide	Other / unclassified	1000 mg/m2	Intravenous
Subject	Mycophenolate Sodium	Unknown	720 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications