Long-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis
NCT ID: NCT01056237
Last Updated: 2015-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
206 participants
INTERVENTIONAL
2010-02-28
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Multi-target therapy
(Tarcrolimus+mycophenolate mofetil)
Multi-target therapy
Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)
Azathioprine
Aza
Azathioprine
1.0-2.0mg/kg/d
Interventions
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Multi-target therapy
Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)
Azathioprine
1.0-2.0mg/kg/d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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. -
18 Years
65 Years
ALL
No
Sponsors
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Zhi-Hong Liu, M.D.
OTHER
Responsible Party
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Zhi-Hong Liu, M.D.
professor
Principal Investigators
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zhihong Liu, Master
Role: PRINCIPAL_INVESTIGATOR
Research Institute of Nephrology, Jinling Hospital
Locations
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Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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NJCT-1002
Identifier Type: -
Identifier Source: org_study_id
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