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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Nanjing University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01056237
First received: January 21, 2010
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

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: Tacrolimus+mycophenolate mofetil
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 Aza [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: February 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multi target therapy
MMF+FK506
Drug: Tacrolimus+mycophenolate mofetil
Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)
Other Name: FK506,MMF
Active Comparator: Azathioprine Drug: Azathioprine
1.0-2.0mg/kg/d
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.

  Eligibility

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

Inclusion Criteria:

  1. Patients who signed written informed consent form
  2. SLE patient, aged between 18-60 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 9 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
  5. 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.

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. -
  Contacts and Locations
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

Locations
China, Jiangsu
Research Institute of Nephrology, Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Haitao Zhang, Master    0086-25-80860218    haitaozh@yahoo.com.cn   
Principal Investigator: Zhihong Liu, Master         
Sponsors and Collaborators
Zhi-Hong Liu, M.D.
Investigators
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: March 29, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014