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

Research Institute of Nephrology, Jinling Hospital,

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.

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.

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. -