Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2002

Primary Completion Date

May 31, 2008

Study Completion Date

April 30, 2009

Conditions
Systemic Lupus ErythematosusLupus Nephritis
Interventions
DRUG

Cyclosporine A

Cyclosporine arm (CyA group) consisted of oral cyclosporine A (CyA) 4-5mg/kg/day (given in two divided doses) for 9 months followed by gradually decreasing dose of cyclosporine (3.75-1.25 mg/kg/day) within the next 9 months. The dosage of concomitant glucocorticoids was driven and tapered according to a single treatment protocol.

DRUG

Cyclophosphamide

Cyclophosphamide (CPH) therapeutic arm (CPH group) consisted of 8 boluses of intravenous cyclophosphamide (10mg/kg) given within 9 months in subsequently prolonged intervals (2x3weeks, 4x4 weeks, 2x6 weeks) followed by 4-5 oral cyclophosphamide boluses (10mg/d in 6-8 week intervals). The dosage of concomitant glucocorticoids was driven and tapered according to a single treatment protocol.

Trial Locations (4)

12800

Department of Nephrology, General Teaching Hospital and First faculty of Medicine, Charles University in Prague, Prague

12850

Institute of Rheumatology, Prague

Unknown

Department of Rheumatology, Faculty of Medicine, Charles University in Prague, Hradec Králové

Department of Rheumatology, Faculty of Medicine, Palacky University, Olomouc

All Listed Sponsors
collaborator

Ministry of Health, Czech Republic

OTHER_GOV

collaborator

Charles University, Czech Republic

OTHER

collaborator

Palacky University

OTHER

collaborator

Department of Rheumatology, Hospital, Ceske Budejovice, Czech Republic

UNKNOWN

collaborator

National Institute of Rheumatology, Piestany, Slovakia

UNKNOWN

collaborator

St. Anna Hospital, Brno, Czech

OTHER

lead

Institute of Rheumatology, Prague

OTHER

NCT00976300 - Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study | Biotech Hunter | Biotech Hunter