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. -
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 19, 2014
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs