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

Zhi-Hong Liu, M.D.

Status: Completed

Conditions: Lupus Nephritis

Treatments: Drug: Azathioprine; Drug: Multi-target therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01056237

NJCT-1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Multi-target therapy

Experimental group

Description:

(Tarcrolimus+mycophenolate mofetil)

Treatment:

Drug: Multi-target therapy

Azathioprine

Active Comparator group

Description:

Aza

Treatment:

Drug: Azathioprine