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

Not Applicable

Completed

• Conditions: Lupus Nephritis
• Interventions: Drug: Azathioprine; Drug: Multi-target therapy

• Registration Number: NCT01056237
• Lead Sponsor: Zhi-Hong Liu, M.D.

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.

Study Timeline

• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Study Start: 2010-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azathioprine	Azathioprine	Aza
Multi-target therapy	Multi-target therapy	(Tarcrolimus+mycophenolate mofetil)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Research Institute of Nephrology, Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China