Long-Term Study of Multi-target Therapy as Continuous Induction and Maintenance Treatment for Lupus Nephritis
Verified March 2013 by Nanjing University School of Medicine
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
First received: January 21, 2010
Last updated: March 29, 2013
Last verified: March 2013
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.
Drug: Tacrolimus+mycophenolate mofetil
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Research Institute of Nephrology, Jinling Hospital,
Primary Outcome Measures:
- To compare the efficacy and safety of Aza [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
Experimental: Multi target therapy
Drug: Tacrolimus+mycophenolate mofetil
Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)
Other Name: FK506,MMF
Active Comparator: Azathioprine
Other Name: Aza
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.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients who signed written informed consent form
- SLE patient, aged between 18-60 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 9 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
- Patients were recruited when received partial remission or complete remission after 9 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.
- 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. -
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01056237
|Research Institute of Nephrology, Jinling Hospital
|Nanjing, Jiangsu, China, 210002 |
|Contact: Haitao Zhang, Master 0086-25-80860218 firstname.lastname@example.org |
|Principal Investigator: Zhihong Liu, Master |
Zhi-Hong Liu, M.D.
||zhihong Liu, Master
||Research Institute of Nephrology, Jinling Hospital
No publications provided
||Zhi-Hong Liu, M.D., professor, Nanjing University School of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 21, 2010
||March 29, 2013
||China: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 01, 2014
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action