We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00371319
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: tacrolimus Drug: mycophenolate mofetil Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
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
Study Start Date : September 2005
Primary Completion Date : May 2014
Study Completion Date : June 2014


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Posted: September 4, 2006    Key Record Dates
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
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents