Multicenter Registry of Pediatric Lupus Nephritis in China

Sponsor
Xiqiang Dang
Study ID
NCT03791827
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Corticosteroid — DRUG
    corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
  • Hydroxychloroquine — DRUG
    Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
  • Cyclophosphamide — DRUG
    The typical therapy for cyclophosphamide is either 500 to 750mg/m2 once every month for 6 doses or 8 to 12 mg/kg/d for two consecutive days every two weeks for 6 to 8 doses through i.v.
  • Mycophenolate Mofetil — DRUG
    The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d
  • Azathioprine — DRUG
    The recommended dose of azathioprine is 1.5 to 2mg/kg/d
  • Tacrolimus — DRUG
    The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h
  • Cyclosporine A — DRUG
    The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h
  • Rituximab — DRUG
    The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses

Study Details

This study is designed to evaluate the efficacy and safety of the current treatment option and outcome of pediatric lupus nephritis patients in China. Investigators will perform prospective registration study among at least 35 pediatric nephrology medical centers in China.

Key Dates

Start date
Dec 1, 2018
Status verified
Apr 2019
Primary completion
Nov 30, 2023
Completion
Nov 30, 2024

Study Design

Enrollment
1,200 participants (estimated)

Arms

  • Arm: Corticosteroid
    Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid
  • Arm: Corticosteroid and cyclophosphamide
    Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide
  • Arm: Corticosteroid and mycophenolate mofetil
    Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil
  • Arm: Corticosteroid and azathioprine
    Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine
  • Arm: Corticosteroid and tacrolimus
    Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus
  • Arm: Corticosteroid and cyclosporine A
    Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A
  • Arm: Corticosteroid, mycophenolate mofetil and tacrolimus
    Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
  • Arm: Retuximab
    An option for refractory lupus nephritis

Primary Outcome Measure

Complete remission [ Time Frame: 5 years ]

Central Contacts

Related Studies