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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371319
First Posted: September 4, 2006
Last Update Posted: July 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital
  Purpose
The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.

Condition Intervention Phase
Lupus Nephritis Drug: tacrolimus Drug: mycophenolate mofetil Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Compare the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

Resource links provided by NLM:


Further study details as provided by Chi Chiu Mok, Tuen Mun Hospital:

Primary Outcome Measures:
  • remission rate [ Time Frame: month 6 ]

Secondary Outcome Measures:
  • renal function deterioration, relapse and mortality [ Time Frame: month 60 ]

Enrollment: 150
Study Start Date: September 2005
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tacrolimus
Tacrolimus treatment
Drug: tacrolimus
0.06-0.1 mg/kg/day
Other Name: Prograf
Active Comparator: mycophenolate mofetil
mycophenolate mofetil
Drug: mycophenolate mofetil
2-3 gm/day
Other Name: Cellcept

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who refuse to be randomized for treatment
  2. Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
  3. Serum creatinine >= 200 umol/L at the time of randomization
  4. Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
  5. Patients who are pregnant or plan for pregnancy within 12 months after randomization
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371319


Locations
China
Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
Tuen Mun Hospital
Investigators
Principal Investigator: CC MOK, MD, FRCP Tuen Mun Hospital, Hong Kong
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital
ClinicalTrials.gov Identifier: NCT00371319     History of Changes
Other Study ID Numbers: HARECCTR0500018
First Submitted: September 1, 2006
First Posted: September 4, 2006
Last Update Posted: July 2, 2014
Last Verified: July 2014

Keywords provided by Chi Chiu Mok, Tuen Mun Hospital:
lupus
nephritis
tacrolimus
mycophenolate mofetil

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents