Long-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis

Research Institute of Nephrology, Jinling Hospital,

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01056237

Enrollment

206

Registered

2010-01-26

Start date

2010-02-28

Completion date

2013-06-30

Last updated

2015-07-31

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

Conditions

Lupus Nephritis

Brief summary

An multi-site, randomized, prospective study to compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza therapy.

Detailed description

Azathioprine (AZA) has been used for maintenance therapy of lupus nephritis for many years. We compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment vs CTX-Aza.

Interventions

DRUGMulti-target therapy

Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)

DRUGAzathioprine

1.0-2.0mg/kg/d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Patients who signed written informed consent form 2. SLE patient, aged between 18-65 years, female or male; 3. Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy 4. All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses. 5. Patients were recruited when received partial remission or complete remission after 6 months induction therapy. Complete remission: proteinuria \<0.4 g/24h, negative urine sediment, serum albumin \>35 g/L, elevated scr \<0.3mg/dl, no extra-renal complications; Partial remission: proteinuria \<1.0 g/24h, urine RBC \<50X104/ml without casts, serum albumin \> 30 g/L, elevated Scr \<0.3mg/dl,no extra-renal complications.

Exclusion criteria

1. Patients who didn't sign written informed consent form or could not obey the protocol. 2. Patients who didn't received the CR or PR criterion. 3. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis. 4. WBC \<3000/mm3 in peripheral blood . 5. Patients with central nervous system symptoms. -

Design outcomes

Primary

Measure	Time frame
To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.	18 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026