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

This study has been completed.
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
First received: January 21, 2010
Last updated: July 30, 2015
Last verified: July 2015
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.

Condition Intervention
Lupus Nephritis
Drug: Multi-target therapy
Drug: Azathioprine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Research Institute of Nephrology, Jinling Hospital,

Resource links provided by NLM:

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 206
Study Start Date: February 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multi-target therapy
(Tarcrolimus+mycophenolate mofetil)
Drug: Multi-target therapy
Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)
Other Name: Tacrolimus+mycophenolate mofetil
Active Comparator: Azathioprine
Drug: Azathioprine
Other Name: Aza

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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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:

  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. -
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01056237

China, Jiangsu
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Zhi-Hong Liu, M.D.
Principal Investigator: zhihong Liu, Master Research Institute of Nephrology, Jinling Hospital
  More Information

No publications provided

Responsible Party: Zhi-Hong Liu, M.D., professor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT01056237     History of Changes
Other Study ID Numbers: NJCT-1002
Study First Received: January 21, 2010
Last Updated: July 30, 2015
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Lupus Nephritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Kidney Diseases
Lupus Erythematosus, Systemic
Urologic Diseases
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2015