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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT00371319
First received: September 1, 2006
Last updated: July 1, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Tuen Mun Hospital:

Primary Outcome Measures:
  • remission rate [ Time Frame: month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • renal function deterioration, relapse and mortality [ Time Frame: month 60 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital
ClinicalTrials.gov Identifier: NCT00371319     History of Changes
Other Study ID Numbers: HARECCTR0500018
Study First Received: September 1, 2006
Last Updated: July 1, 2014
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Tuen Mun Hospital:
lupus
nephritis
tacrolimus
mycophenolate mofetil

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

ClinicalTrials.gov processed this record on August 19, 2014