Skip to content

A randomized controlled study on the treatment of lupus nephritis

A randomized controlled study on the treatment of active lupus nephritis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000896
Enrollment
Unknown
Registered
2010-06-09
Start date
2010-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Active lupus nephritis

Interventions

A:MMF 0.75~1.0g/d in induction stage, MMF0.5~0.75g/d in maintenance stage
B:FK506 0.1mg/kg/d in induction stage, FK506 0.05mg/kg/d in maintenance stage
C:Intravenous CYC was given in monthly pulses of 0.5-0.75g/m2 in induction stage, Aza 1-2mg/kg/d in maintenance stage

Sponsors

Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who aged 18 to 65 years and had a diagnosis of systemic lupus erythematosus, as defined by the 1997 revised American Rheumatism Association criteria; 2. Renal biopsy showing active lupus nephritis (classes III, IV-S or IV-G, V, III+V, or IV+V according to the 2003 International Society of Nephrology/Renal Pathology Society classification); 3. urinary protein excretion of 1.0 g/24 h or above; 4. With informed consent signed.

Exclusion criteria

Exclusion criteria: 1. Treatment with MMF, tacrolimus, cyclosporine or IVC within the previous year; 2. Serum creatinine concentration >4.52 mg/dl (400 umol/L); 3. Life-threatening complications such as cerebral lupus, pancreatitis, gastrointestinal hemorrhage within 6 momths or active peptic ulcer within 3 months, severe infection, severe cardiovascular disease, bone marrow insufficiency with cytopenias not attributable to SLE; 4. Poor drug compliance.

Design outcomes

Primary

MeasureTime frame
Complete remission rate;

Countries

China

Contacts

Public ContactNan Chen
chen-nan@medmail.com.cn+86 21 64370045-665233

Outcome results

None listed

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