Comparison Between Tacrolimus (TAC) and Mycophenolate Mofetil (MMF) for Induction of Remission in Lupus Nephritis

NACompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

March 31, 2017

Study Completion Date

March 31, 2017

Conditions
Lupus Nephritis
Interventions
DRUG

Tacrolimus vs. Mycophenolate mofetil for Induction Therapy in Lupus Nephritis

Patients were randomly assigned to receive regimen I or II: TAC plus prednisolone (TAC group) or MMF plus prednisolone (MMF group). TAC was started at a dosage of 0.1 mg/kg/day divided into 2 daily doses at 12-hour intervals, and the dosage was titrated to achieve trough blood concentrations of 6-10 ng/mL in the first and second month and then 4-8 ng/mL., thereafter. MMF was initiated at a dose of 500 mg twice daily (for patients \> 50 Kg and Estimated Glomerular Filtration rate (eGFR) \> 60 ml/min) for 2 weeks, and advanced to 750 mg twice daily in LN patients weighing less than 50 kg or 1,000 mg twice daily in LN patients weighing 50 kg or more. Patients received concomitant prednisone at a dose of 0.5-0.7 mg/kg/d (maximum 60 mg/day), with tapering by 5-10 mg/day every 2 weeks until a dose of 5 mg/d has been achieved, and this dosage was maintained until the end of 24 weeks.

Trial Locations (1)

10400

Ramathibodi Hospital, Rahathevi

All Listed Sponsors
collaborator

King Chulalongkorn Memorial Hospital

OTHER

collaborator

Maharaj Nakorn Chiang Mai Hospital

OTHER

collaborator

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

collaborator

Srinagarind Hospital, Khon Kaen University

OTHER

collaborator

Siriraj Hospital

OTHER

collaborator

Songklanagarind Hospital

UNKNOWN

lead

Ramathibodi Hospital

OTHER

NCT01580865 - Comparison Between Tacrolimus (TAC) and Mycophenolate Mofetil (MMF) for Induction of Remission in Lupus Nephritis | Biotech Hunter | Biotech Hunter