Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis. (MAINTAIN)

• ClinicalTrials.gov Identifier: NCT00204022
• Recruitment Status: Completed
• First Posted: September 20, 2005
• Last Update Posted: October 14, 2011
• Sponsor: Frédéric A. Houssiau, MD, PhD
• Information provided by (Responsible Party): Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 20, 2005
• Last Update Posted Date: October 14, 2011
• Study Start Date: February 2001
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 17, 2011): Time to renal flare [ Time Frame: 5 years ]
• Original Primary Outcome Measures (submitted: September 12, 2005): Time to renal flare

Current Secondary Outcome Measures (submitted: August 17, 2011)

• Number of withdrawals due to toxicity [ Time Frame: 5 years and 10 years ]
• Cumulated glucocorticoid intake [ Time Frame: 5 years and 10 years ]
• Number of treatment failures [ Time Frame: 5 years and 10 years ]
• 24-hour proteinuria over time [ Time Frame: 5 years and 10 years ]
• Serum creatinine titers [ Time Frame: 5 years and 10 years ]
• Time to renal flare [ Time Frame: 10 years ]

Original Secondary Outcome Measures (submitted: September 12, 2005)

• Number of withdrawals due to toxicity
• Cumulated glucocorticoid intake
• Number of treatment failures
• 24-hour proteinuria over time
• Renal function over time

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.
• Official Title: A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.
• Brief Summary: The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.
• Detailed Description: Proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (SLE) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (IV) cyclophosphamide (CYC). The objective of the MAINTAIN Nephritis Trial is to compare mycophenolate mofetil (MMF) and azathioprine (AZA), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course IV CYC regimen. The hypothesis addressed by the MAINTAIN Nephritis Trial is that MMF is superior to AZA.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lupus Nephritis

Intervention

• Drug: Mycophenolate mofetil
  Mycophenolate mofetil
• Drug: Azathioprine
  Azathioprine

Study Arms

• Experimental: 1
  Mycophenolate mofetil (target dose 2g/day)
  Intervention: Drug: Mycophenolate mofetil
• Active Comparator: 2
  Azathioprine (target dose 2mg/kg/day)
  Intervention: Drug: Azathioprine

Publications *

• Tamirou F, Lauwerys BR, Dall'Era M, Mackay M, Rovin B, Cervera R, Houssiau FA; MAINTAIN Nephritis Trial Investigators. A proteinuria cut-off level of 0.7 g/day after 12 months of treatment best predicts long-term renal outcome in lupus nephritis: data from the MAINTAIN Nephritis Trial. Lupus Sci Med. 2015 Nov 12;2(1):e000123. doi: 10.1136/lupus-2015-000123. eCollection 2015.
• Tamirou F, D'Cruz D, Sangle S, Remy P, Vasconcelos C, Fiehn C, Ayala Guttierez Mdel M, Gilboe IM, Tektonidou M, Blockmans D, Ravelingien I, le Guern V, Depresseux G, Guillevin L, Cervera R, Houssiau FA; MAINTAIN Nephritis Trial Group. Long-term follow-up of the MAINTAIN Nephritis Trial, comparing azathioprine and mycophenolate mofetil as maintenance therapy of lupus nephritis. Ann Rheum Dis. 2016 Mar;75(3):526-31. doi: 10.1136/annrheumdis-2014-206897. Epub 2015 Mar 10.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 8, 2011): 105
• Original Enrollment (submitted: September 12, 2005): 102
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• SLE aged ≥ 14 years
• Proteinuria ≥ 500 mg/day
• Biopsy-proven proliferative lupus nephritis

Exclusion Criteria:

• Recent treatment with high-dose glucocorticoids
• Recent treatment with immunosuppressive drugs
• More exclusion criteria in the protocol

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT00204022
• Other Study ID Numbers: EWPSLE-LN-02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain
• Study Sponsor: Frédéric A. Houssiau, MD, PhD
• Collaborators: Not Provided

Investigators

• Principal Investigator: Frédéric A Houssiau, MD, PhD; Université Catholique de Louvain

• PRS Account: Université Catholique de Louvain
• Verification Date: October 2011