Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298506
Status:
COMPLETED
Last Update Posted:
2011-09-29
First Post:
2006-03-01
Brief Title:
Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil MMF in Lupus Nephritis IIIIVV
Sponsor:
Nanjing University School of Medicine
Organization:
Nanjing University School of Medicine
Study Overview
Official Title:
An Open Prospective Study to Assess the Efficacy and Safety of FK506 Combined MMF in the Treatment of Class IIIIVV IV or V III Lupus Nephritis
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open prospective study to assess the efficacy and safety of Tacrolimus FK506 combined with MMF in the treatment of class III IV V IV or V III lupus nephritis
Detailed Description:
1 To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ Ⅳ Ⅴ Ⅳ or Ⅴ Ⅲ LN
2 To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ Ⅳ Ⅴ Ⅳ or Ⅴ Ⅲ LN
3 To explore the dosing of FK506 combined with MMF and their effective range of blood concentration
2 To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ Ⅳ Ⅴ Ⅳ or Ⅴ Ⅲ LN
3 To explore the dosing of FK506 combined with MMF and their effective range of blood concentration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None