NCT01056237CompletedNot Applicable
Research Institute of Nephrology, Jinling Hospital,
Zhi-Hong Liu, M.D.1 site in 1 country206 target enrollmentStarted: February 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who signed written informed consent form
- •SLE patient, aged between 18-65 years, female or male;
- •Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy
- •All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
- •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
- •Patients who didn't sign written informed consent form or could not obey the protocol.
- •Patients who didn't received the CR or PR criterion.
- •Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
- •WBC <3000/mm3 in peripheral blood .
- •Patients with central nervous system symptoms. -
Arms & Interventions
Multi-target therapy
Experimental
(Tarcrolimus+mycophenolate mofetil)
Intervention: Multi-target therapy (Drug)
Azathioprine
Active Comparator
Aza
Intervention: Azathioprine (Drug)
Outcomes
Primary Outcomes
To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.
Time Frame: 18 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Zhi-Hong Liu, M.D.
professor
Nanjing University School of Medicine
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Assess the Efficacy and Safety of Multi-target Therapy in Lupus NephritisLupus NephritisNCT00876616Zhi-Hong Liu, M.D.362
Recruiting
Not Applicable
Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter StudyArterial Pulmonary Hypertension (PAH)NCT06753981Qianfoshan Hospital48
Completed
Phase 3
Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONICCrohn DiseaseNCT00094458Centocor Ortho Biotech Services, L.L.C.508
Terminated
Phase 3
Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive SurgeryCorneal EctasiaKeratoconusNCT01459679American-European Congress of Ophthalmic Surgery1,721
Completed
Phase 2
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.Tick-borne EncephalitisNCT00161798Pfizer