Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory 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. Identifier: NCT01203709
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : March 4, 2014
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital

Brief Summary:
A trial of combination of two drugs for the treatment of refractory lupus nephritis.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: low dose combination of MMF and Tac Phase 4

Detailed Description:
Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-dose Combination of Mycophenolate Mofetil and Tacrolimus for Refractory Lupus Nephritis: a 12-month Prospective Study
Study Start Date : August 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: Combination treatment
treatment arm
Drug: low dose combination of MMF and Tac
mycophenolate mofetil 500mg BID + tacrolimus 2mg BID
Other Name: Cellcept and Prograf

Primary Outcome Measures :
  1. Clinical remission rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]
    adverse events experienced by patients as a measure of tolerability

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Active nephritis documented by renal biopsy within 24 months of entry;
  2. Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
  3. Serum creatinine (Scr) less than 200umol/L.

Exclusion Criteria:

  1. Previous intolerance to either MMF/Tac;
  2. Scr >200umol/L;
  3. Informed consent unavailable.

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 identifier (NCT number): NCT01203709

Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
Tuen Mun Hospital
Principal Investigator: CC Mok, MD, FRCP Tuen Mun Hospital, Hong Kong China

Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital Identifier: NCT01203709     History of Changes
Other Study ID Numbers: NTWC/CREC/837/10
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014

Keywords provided by Chi Chiu Mok, Tuen Mun Hospital:

Additional relevant MeSH terms:
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
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