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Completed

NCT Number: NCT00371319

Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.

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Key information

Conditions

Lupus Nephritis Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tuen Mun Hospital

Hong Kong, China

About this study

Patients with biopsy proven active lupus nephritis will be randomized to receive tacrolimus or mycophenolate mofetil, on top of corticosteroids, for initial treatment. Efficacy and adverse effects will be compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who fulfill at least 4 of the ACR criteria for SLE
  • Age >= 18 years
  • Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
  • Serum creatinine < 200 umol/L at the time of randomization

Exclusion criteria

  • Patients who refuse to be randomized for treatment
  • Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
  • Serum creatinine >= 200 umol/L at the time of randomization
  • Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
  • Patients who are pregnant or plan for pregnancy within 12 months after randomization

Treatment and study plan

Tacrolimus

Drug

0.06-0.1 mg/kg/day

Other names: Prograf

Mycophenolate mofetil

Drug

2-3 gm/day

Other names: Cellcept

Primary outcomes

  1. remission rate

    Time frame: month 6

Secondary outcomes

  1. renal function deterioration, relapse and mortality

    Time frame: month 60

Sponsors and collaborators

Lead sponsor

Tuen Mun Hospital

Other Gov

Registry information

Official study title

To Compare the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Sep 4, 2006
Registry last updated
Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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