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

Lupus Nephritis Clinical Trial

Official title:

Research Institute of Nephrology, Jinling Hospital,

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056237
• Other study ID #: NJCT-1002
• Status: Completed
• Phase: N/A
• First received: January 21, 2010
• Last updated: July 30, 2015
• Start date: February 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2015
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ?, ?,?+?, ?+? or ? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Multi-target therapy
Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)
• Azathioprine
1.0-2.0mg/kg/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhi-Hong Liu, M.D.

Country where clinical trial is conducted

China, 

Outcome

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