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

October 27, 2008 updated by: Sun Yat-sen University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The 1st Affiliated Hospital, Sun Yet-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Remission rate
Time Frame: 2006-2008
2006-2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal function, proteinuria, relapse.
Time Frame: 2006-2008
2006-2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2008

Last Update Submitted That Met QC Criteria

October 27, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-PRGLN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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