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

Summary

Intravenous cyclophosphamide is considered to be the standard of care for treatment of proliferative lupus nephritis. However, its use is limited by potentially severe toxic effects. Cyclosporine A has been suggested to be an efficient and safe treatment alternative to cyclophosphamide. In a randomized, multicenter, open-label, controlled trial the investigators sought to compare the efficacy of oral cyclosporine A with intravenous pulse cyclophosphamide to induce durable remission in patients with lupus nephritis III-IV.

Conditions

• Systemic Lupus Erythematosus
• Lupus 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.

Sponsors & Collaborators

• Ministry of Health, Czech Republic

  collaborator OTHER_GOV

• Charles University, Czech Republic

  collaborator OTHER

• Palacky University

  collaborator OTHER

• Department of Rheumatology, Hospital, Ceske Budejovice, Czech Republic

  collaborator UNKNOWN

• National Institute of Rheumatology, Piestany, Slovakia

  collaborator UNKNOWN

• St. Anna Hospital, Brno, Czech

  collaborator OTHER

• Institute of Rheumatology, Prague

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-01-31

Primary Completion

2008-05-31

Completion

2009-04-30

Countries

• Czechia

Study Locations