Mycophenolate Mofetil Versus Azathioprine for Maintenance... | NCT00204022

Studies
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

NCT00204022

Sponsor

Frédéric A. Houssiau, MD, PhD

Status

Completed

Last Update Posted

Oct 14, 2011Estimated

Enrollment

105Actual

Phase

Phase 3

Conditions

Lupus Nephritis

Interventions

Mycophenolate mofetil
Azathioprine

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2001

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2011

Last Update Posted Date

Oct 14, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frédéric A. Houssiau, MD, PhD, Professeur Ordinaire, Chef de Service Clinique, Université Catholique de LouvainSponsor-Investigator

Lead Sponsor

Frédéric A. Houssiau, MD, PhDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mycophenolate mofetil	Drug	Mycophenolate mofetil	1
Azathioprine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to renal flare		5 years

Secondary Outcomes

Measure	Description	Time Frame
Number of withdrawals due to toxicity		5 years and 10 years
Cumulated glucocorticoid intake		5 years and 10 years
Number of treatment failures

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frédéric A Houssiau, MD, PhD	Université Catholique de Louvain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Université catholique de Louvain		Brussels		B-1200	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26629352	Derived	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.
25757867

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D009173	Mycophenolic Acid
D001379	Azathioprine

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals