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Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT02949349
Recruitment Status : Completed
First Posted : October 31, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Genovate Biotechnology Co., Ltd.,

Brief Summary:
This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Mycophenolate mofetil Drug: Azathioprine Drug: Prednisolone Phase 2

Detailed Description:
This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day & 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
Study Start Date : July 2015
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : January 25, 2017


Arm Intervention/treatment
Experimental: MMF 500mg
Mycophenolate mofetil 500mg, PO BID
Drug: Mycophenolate mofetil
Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.
Other Name: Mycocep Capsules

Drug: Prednisolone
Daily dose not more than 10mg, orally, for 24 weeks.

Experimental: MMF 750mg
Mycophenolate mofetil 750mg, PO BID
Drug: Mycophenolate mofetil
Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.
Other Name: Mycocep Capsules

Drug: Prednisolone
Daily dose not more than 10mg, orally, for 24 weeks.

Active Comparator: AZA
Azathioprine 1mg/kg, PO BID
Drug: Azathioprine
Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.
Other Name: Imuran Azathioprine Tablets

Drug: Prednisolone
Daily dose not more than 10mg, orally, for 24 weeks.




Primary Outcome Measures :
  1. Change in serum albumin [ Time Frame: 24 weeks treatment ]
  2. Change in serum creatinine [ Time Frame: 24 weeks treatment ]
  3. Change in spot urine protein/creatinine ratio [ Time Frame: 24 weeks treatment ]

Secondary Outcome Measures :
  1. Change in serum albumin [ Time Frame: 12 weeks treatment ]
  2. Change in serum creatinine [ Time Frame: 12 weeks treatment ]
  3. Change in spot urine protein/creatinine ratio [ Time Frame: 12 weeks treatment ]
  4. Change in cholesterol [ Time Frame: 24 weeks treatment ]
  5. Change in triglyceride [ Time Frame: 24 weeks treatment ]
  6. Change in complete blood count/differential count (CBC/DC) [ Time Frame: 24 weeks treatment ]
  7. Change in number of subjects with doubling of serum creatinine [ Time Frame: 24 weeks treatment ]
  8. Change in the average daily dose of oral prednisolone [ Time Frame: 24 weeks treatment ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of lupus nephritis.
  • Currently receiving maintenance therapy with Azathioprine, Mycophenolate Mofetil, Mycophenolate Sodium, or Cyclosporine for lupus nephritis for at least 3 months prior to randomization.
  • Stable use of low dose (≤10mg/day) oral prednisolone for lupus nephritis for at least 3 months prior to randomization.

Exclusion Criteria:

  • Untreated, not in need of immunosuppressive treatment (in addition to corticosteroids), currently receiving induction therapy, or not responding to Azathioprine, Mycophenolate Mofetil or Mycophenolate Sodium as induction or maintenance therapy for lupus nephritis.
  • Currently receiving or anticipated to receive cyclophosphamide or IV pulse of corticosteroids.
  • Currently receiving continuous dialysis starting more than 2 weeks before randomization, and/or with an anticipated duration of more than 8 weeks.
  • Previous kidney transplant or planned transplant.
  • Presence of life threatening complications such as cerebral lupus or severe infection.
  • Presence of liver dysfunction.
  • Presence of COPD or asthma requiring oral steroids.
  • Presence of bone marrow insufficiency or pure red cell aplasia unrelated to active systemic lupus erythematosus.
  • Presence of persistent hematuria or pyuria for causes other than lupus nephritis.

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): NCT02949349


Sponsors and Collaborators
Genovate Biotechnology Co., Ltd.,
Investigators
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Principal Investigator: Ming-Han Chen, M.D., Ph.D. Taipei Veterans General Hospital, Taiwan, R.O.C.

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Responsible Party: Genovate Biotechnology Co., Ltd.,
ClinicalTrials.gov Identifier: NCT02949349     History of Changes
Other Study ID Numbers: GBL15-001
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Genovate Biotechnology Co., Ltd.,:
Systemic Lupus Erythematosus
Lupus Nephritis
Mycophenolate Mofetil
Azathioprine
Maintenance Therapy
Prednisolone
Serum albumin
Serum creatinine
Spot urine protein/creatinine ratio

Additional relevant MeSH terms:
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Lupus Nephritis
Lupus Erythematosus, Systemic
Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Prednisolone
Methylprednisolone Hemisuccinate
Azathioprine
Methylprednisolone Acetate
Methylprednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists