Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00615173
First received: February 1, 2008
Last updated: October 27, 2008
Last verified: October 2008
  Purpose

The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V).

To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V).


Condition Intervention Phase
Kidney Diseases
Lupus Nephritis
Tacrolimus
Induction Phase
Maintenance Phase
Drug: tacrolimus (FK506)
Drug: cyclophosphamide or azathioprine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Remission rate [ Time Frame: 2006-2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Renal function, proteinuria, relapse. [ Time Frame: 2006-2008 ] [ Designated as safety issue: Yes ]

Enrollment: 81
Study Start Date: July 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
tacrolimus(fk506) treatment in induction and maintenance phase
Drug: tacrolimus (FK506)
Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;
Active Comparator: 2
intravenous cyclophosphamide pulses treatment in induction phase; and Aza in the maintenance phase
Drug: cyclophosphamide or azathioprine
Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects of either sex, 14-65 years of age;
  2. Diagnosis of SLE according to the ACR criteria(1997);
  3. Kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V;
  4. Class IV LN: proteinuria >1g/24hr or Scr>115umol/L;
  5. Class III or V LN: proteinuria >2g/24hr or Scr>115umol/L;
  6. Provision of written informed consent by subject or guardian.

Exclusion Criteria:

  1. Inability or unwillingness to provide written informed consent ;
  2. Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
  3. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
  4. Pregnancy, nursing or use of a non-reliable method of contraception;
  5. Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
  6. Previous kidney transplant or planted transplant;
  7. Scr > 4mg/dl (353umol/L);
  8. Active hepatitis, with liver dysfunction;
  9. Diagnosed DM;
  10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
  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: NCT00615173

Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Xue Qing Yu, MD Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Ping Fu, MD Department of Nephrology, West China Hospital of Sichuan University
Principal Investigator: Yun Hua Liao, MD Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University
Principal Investigator: Jin li Zhang, MD Department of nephrology, People's Hospital of Yunnan Province
Principal Investigator: Jian Chen, MD Department of Nephrology, Fuzhou Military General Hospital
Principal Investigator: Tan Qi Lou, MD Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University
Principal Investigator: Yao zhong Kong, MD Department of Nephrology, 1st People's Hospital of Foshan
Principal Investigator: Jun zhou Fu, MD Department of Nephrology,1st People's Hospital of Guangzhou
Principal Investigator: Wei Shi, MD Department of Nephrology, People's Hospital Guangdong Provincial
Principal Investigator: Zheng rong Liu, MD Department of Nephrology, Nanfang Hospital of Southern Medical University
  More Information

No publications provided by Sun Yat-sen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xueqing Yu, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00615173     History of Changes
Other Study ID Numbers: SYSU-PRGLN-001
Study First Received: February 1, 2008
Last Updated: October 27, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Tacrolimus
lupus nephritis

Additional relevant MeSH terms:
Kidney Diseases
Lupus Nephritis
Nephritis
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Tacrolimus
Azathioprine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on September 18, 2014