Research Institute of Nephrology, Jinling Hospital,

Zhi-Hong Liu, M.D.1 site in 1 country206 target enrollmentFebruary 2010

ConditionsLupus Nephritis

InterventionsMulti-target therapy Azathioprine

DrugsMulti-target therapy Azathioprine

Overview

Phase: Not Applicable
Intervention: Multi-target therapy
Conditions: Lupus Nephritis
Sponsor: Zhi-Hong Liu, M.D.
Enrollment: 206
Locations: 1
Primary Endpoint: To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

June 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhi-Hong Liu, M.D.

Responsible Party

Sponsor Investigator

Principal Investigator

Zhi-Hong Liu, M.D.

professor

Nanjing University School of Medicine

Eligibility Criteria

Inclusion Criteria

•Patients who signed written informed consent form
•SLE patient, aged between 18-65 years, female or male;
•Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy
•All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
•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

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