Enteric coat mycophenolate sodium versus intravenous cyclophosphamide for severe paediatric lupus nephritis
| ISRCTN | ISRCTN66475575 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66475575 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/07/2009
- Registration date
- 29/07/2009
- Last edited
- 29/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Wattana Chartapisak
Scientific
Scientific
Department of Pediatrics
Faculty of Medicine
Chiang Mai University
Chiang Mai
50200
Thailand
| Phone | +66 (0)53 945 412 |
|---|---|
| wchartap@mail.med.cmu.ac.th |
Study information
| Study design | Multicentre open-label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (Thai only) |
| Scientific title | Enteric coat mycophenolate sodium versus intravenous cyclophosphamide for severe paediatric lupus nephritis: a multicentre randomised controlled trial |
| Study objectives | Is oral enteric coated mycophenolate sodium better than intravenous (IV) cyclophosphamide in paediatric lupus nephritis? |
| Ethics approval(s) | Joint Research Ethics Committee, Bangkok, Thailand, approved on the 17th June 2009 (ref: JREC008/2009) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mycophenolate sodium, cyclophosphamide |
| Primary outcome measure | 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 study start date | 15/07/2009 |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/07/2009 |
| Date of final enrolment | 30/06/2012 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Department of Pediatrics
Chiang Mai
50200
Thailand
50200
Thailand
Sponsor information
Thailand Clinical Research Collaboration Network (CRCN)
Research organisation
Research organisation
126/146 Level 4
Boromrajchonnane Nursing School Building
Tiwanond Road Soi 14
Maung
Nontaburi
11000
Thailand
| Phone | +66 (0)2 951 0352 |
|---|---|
| office@crcn.in.th | |
| Website | http://www.crcn.in.th |
Funders
Funder type
Research council
Thailand Clinical Research Collaboration Network (CRCN) and Office of National Research Council of Thailand (Thailand) (ref: CRCN -2552-¢03)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
