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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66475575

Enrollment

120

Registered

2009-07-29

Start date

2009-07-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric lupus nephritis Musculoskeletal Diseases Systemic lupus erythematosus

Interventions

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 fo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026