Condition category
Musculoskeletal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
13/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marc Bijl

ORCID ID

Contact details

University Medical Centre Groningen
Department of Clinical Immunology
P.O. Box 30.001
Groningen
9700 RB
Netherlands
+31 (0)50 3612945
m.bijl@int.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR452

Study information

Scientific title

Comparison of short course cyclophosphamide followed by mycophenolate mofetil versus long course cyclophosphamide in the treatment of proliferative lupus nephritis

Acronym

Study hypothesis

Short course cyclophosphamide followed by mycophenolate mofetil will reduce renal relapses to 33% (versus 10% in patients treated with long-course cyclophosphamide)

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Proliferative lupus nephritis

Intervention

Patients will be randomised between long-cyclophosphamide (six monthly courses, 750 mg/m^2) followed by either six 3-monthly courses cyclophosphamide or mycophelolate mofetil, both regimes in combination with prednisone. After 2 years all patients will continue for another 2 years with maintenance therapy, consisting of azathioprine 2 mg/kg.

Intervention type

Drug

Phase

Not Specified

Drug names

Cyclophosphamide, mycophenolate mofetil

Primary outcome measures

Number of renal relapses

Secondary outcome measures

1. Longitudinal follow-up of creatinine, proteinuria, sediment, complement levels, anti-double stranded deoxyribonucleic acid (anti-dsDNA), Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Systemic Lupus International Collaborating Clinics (SLICC), Dutch lupus nephritis questionnaire, 36-item short form health survey (SF-36), renal histology, IF-skin
2. Extra-renal exacerbations of SLE
3. Pregnancy
4. Death

Overall trial start date

01/01/2003

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 70 years
2. Systemic lupus erythematosus (SLE) (presence of at least 4 American College of Rheumatology [ACR]-criteria for SLE)
3. Proliferative lupus nephritis:
3.1. Biopsy proven lupus nephritis World Health Organization (WHO) class III or IV (according to Churg 1995)
3.2. 'Active sediment': greater than 5 erythrocytes per high powered field (HPF) and/or cel cylinders
3.3. Proteinuria greater than 0.5 g/day
4. Adequate contraception
5. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

124

Participant exclusion criteria

1. Active infection
2. Pregnancy
3. Known allergy for one of the study drugs
4. Malignancy less than 5 years prior to inclusion

Recruitment start date

01/01/2003

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

Sponsor not yet defined (The Netherlands)

Sponsor details

-
-
-
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)

Alternative name(s)

Dutch Kidney Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes