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

This study is currently recruiting participants.
Verified July 2012 by Tuen Mun Hospital
Sponsor:
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT00371319
First received: September 1, 2006
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 100
Study Start Date: June 2004
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (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 diffuse proliferative lupus glomerulonephritis (WHO class IV) or focal proliferative lupus glomerulonephritis (WHO class III) with >= 50% segmental involvement of the glomeruli
  4. Biopsy proven pure membranous lupus nephropathy (WHO class V) with nephrotic syndrome
  5. 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 WHO class I,II, or III (< 50% segmental involvement)
  5. Patients who are pregnant or plan for pregnancy within 12 months after randomization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371319

Contacts
Contact: CC MOK, MD, FRCP ccmok2006@gmail.com

Locations
China
Tuen Mun Hospital Recruiting
Hong Kong, China
Contact: CC MOK, MD, FRCP         ccmok2006@gmail.com    
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 2, 2012
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
Tacrolimus
 Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013