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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056237
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : July 31, 2015
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Multi-target therapy Drug: Azathioprine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Research Institute of Nephrology, Jinling Hospital,
Study Start Date : February 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056237

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China, Jiangsu
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Zhi-Hong Liu, M.D.
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Principal Investigator: zhihong Liu, Master Research Institute of Nephrology, Jinling Hospital
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Responsible Party: Zhi-Hong Liu, M.D., professor, Nanjing University School of Medicine Identifier: NCT01056237    
Other Study ID Numbers: NJCT-1002
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antirheumatic Agents