Condition category
Musculoskeletal Diseases
Date applied
07/07/2009
Date assigned
29/07/2009
Last edited
29/07/2009
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 Wattana Chartapisak

ORCID ID

Contact details

Department of Pediatrics
Faculty of Medicine
Chiang Mai University
Chiang Mai
50200
Thailand
+66 (0)53 945 412
wchartap@mail.med.cmu.ac.th

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Enteric coat mycophenolate sodium versus intravenous cyclophosphamide for severe paediatric lupus nephritis: a multicentre randomised controlled trial

Acronym

Study hypothesis

Is oral enteric coated mycophenolate sodium better than intravenous (IV) cyclophosphamide in paediatric lupus nephritis?

Ethics approval

Joint Research Ethics Committee, Bangkok, Thailand, approved on the 17th June 2009 (ref: JREC008/2009)

Study design

Multicentre open-label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (Thai only)

Condition

Paediatric lupus nephritis

Intervention

Intervention arm:
Enteric coated mycophenolate sodium (myfortic®) 720 - 860 mg/m^2/day via oral administration twice daily + oral steroid.
Total duration of treatment: 12 months
Total duration of follow-up: 12 months

Control arm:
Cyclophosphamide 750 - 1000 mg/m^2/day (maximum dose 1000 mg/day) via intravenous drip monthly for 6 months then every 3 months + oral steroid.
Total duration of treatment: 12 months
Total duration of follow-up: 12 months

Intervention type

Drug

Phase

Not Applicable

Drug names

Mycophenolate sodium, cyclophosphamide

Primary outcome measures

1. Complete and/or partial remission at the end of month 6
2. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score at the end of month 6

Secondary outcome measures

1. Rate of end-stage renal disease (ESRD) or chronic renal failure (CRF) at month 12
2. Death rate
3. Infection rate
4. Gastrointestinal (GI) side-effect rate
5. Rate of relapse
6. Rate of renal relapse
7. Dosage of concomitant steroid

Overall trial start date

15/07/2009

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. 7 - 15 year old children (either sex) who had lupus according to American Rheumatology Association criteria (first the diagnosis time was between 7 - 15 years old)
2. Renal histology revealed lupus nephritis class III or IV according to World Health Organization (WHO) classification:
2.1. Lupus nephritis class III include one of these following:
2.1.1. Nephritic range proteinuria - urine protein/creatinine ratio equal or more than 2
2.1.2. Acute nephritis - oedema, hypertension and haematuria
2.1.3. Renal insufficiency - estimated glomerular filtration rate (eGFR) less than 90
2.2. Lupus nephritis class IV
3. Serum creatinine not more than 3 mg/dl
4. Must stop oral cyclophosphamide for at least 6 month before enter to the trial
5. Parents and child was informed and give the consent to participate the trial

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Renal histopathology showed crescent more than 50% of total glomeruli
2. Previously received immunoglobulins
3. Previously undertaken plasmapheresis
4. Peviously received mycophenolate
5. Previously received intravenous cyclophosphamide
6. Unable to swallow the tablets
7. Known to have serious illness, i.e., cancer, serious infection before entry to the trial

Recruitment start date

15/07/2009

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Thailand

Trial participating centre

Department of Pediatrics
Chiang Mai
50200
Thailand

Sponsor information

Organisation

Thailand Clinical Research Collaboration Network (CRCN)

Sponsor details

126/146 Level 4
Boromrajchonnane Nursing School Building
Tiwanond Road Soi 14
Maung
Nontaburi
11000
Thailand
+66 (0)2 951 0352
office@crcn.in.th

Sponsor type

Research organisation

Website

http://www.crcn.in.th

Funders

Funder type

Research council

Funder name

Thailand Clinical Research Collaboration Network (CRCN) and Office of National Research Council of Thailand (Thailand) (ref: CRCN -2552-¢03)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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