Enteric coat mycophenolate sodium versus intravenous cyclophosphamide for severe paediatric lupus nephritis

Completed

• Conditions: Paediatric lupus nephritis; Musculoskeletal Diseases; Systemic lupus erythematosus

• Registration Number: ISRCTN66475575
• Lead Sponsor: Thailand Clinical Research Collaboration Network (CRCN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified