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

NCT00615173 | Completed Phase 3 DMC

• 1 other identifier: SYSU-PRGLN-001
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Kidney Diseases; Lupus Nephritis; Tacrolimus; Induction Phase; Maintenance Phase

Keywords

Tacrolimus; lupus nephritis

Outcome Measures

Primary Outcomes (1)

• Remission rate

  2006-2008

Secondary Outcomes (1)

• Renal function, proteinuria, relapse.

  2006-2008

Study Arms (2)

1

EXPERIMENTAL

tacrolimus(fk506) treatment in induction and maintenance phase

Drug: tacrolimus (FK506)

2

ACTIVE COMPARATOR

intravenous cyclophosphamide pulses treatment in induction phase; and Aza in the maintenance phase

Drug: cyclophosphamide or azathioprine

Interventions

tacrolimus (FK506) DRUG

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;

1

cyclophosphamide or azathioprine DRUG

Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.

2

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability or unwillingness to provide written informed consent ;
• Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
• Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
• Pregnancy, nursing or use of a non-reliable method of contraception;
• 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;
• Previous kidney transplant or planted transplant;
• Scr \> 4mg/dl (353umol/L);
• Active hepatitis, with liver dysfunction;
• Diagnosed DM;
• Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• Chen W, Tang X, Liu Q, Chen W, Fu P, Liu F, Liao Y, Yang Z, Zhang J, Chen J, Lou T, Fu J, Kong Y, Liu Z, Fan A, Rao S, Li Z, Yu X. Short-term outcomes of induction therapy with tacrolimus versus cyclophosphamide for active lupus nephritis: A multicenter randomized clinical trial. Am J Kidney Dis. 2011 Feb;57(2):235-44. doi: 10.1053/j.ajkd.2010.08.036. Epub 2010 Dec 21.

  PMID: 21177013 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Lupus Nephritis

Interventions

Tacrolimus; Cyclophosphamide; Azathioprine

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: July 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 29, 2008

Record last verified: 2008-10

Locations

CN (1)