Tacrolimus Versus Cyclophosphamide as Treatment for Lupus Nephritis
|ClinicalTrials.gov Identifier: NCT01207297|
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : August 23, 2011
In this comparative open-label cohort study, the investigators compared the efficacy and safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse proliferative and membranous lupus nephritis with severe renal disease. Treatment of lupus nephritis (LN) with cyclophosphamide is effective, but retain a certain proportion of renal function exacerbations. Tacrolimus may be a suitable substitute treatment for CYC.
Methods: Forty patients with diffuse proliferative or membranous were recruited for this trial, 45% of them had lower Ccr (<60mL/min/1.73m2), 10% had increased serum creatinine (>180µmol/L) and 67.5% had nephritic proteinuria (>3.5g/day). The investigators compared the efficacy and adverse effects of TAC (0.04-0.08 mg/kg/d) and prednisone for 12 months (TAC group) with pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone followed by azathioprine (50mg/day）for 6 months (CYC group).
|Condition or disease||Intervention/treatment||Phase|
|SLE Lupus Nephritis Renal Insufficiency End-stage Renal Disease||Drug: Tacrolimus Drug: cyclophosphamide||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tacrolimus Versus Cyclophosphamide as Treatment for Diffuse Proliferative or Membranous Lupus Nephritis: Prospective Cohort Study|
|Study Start Date :||March 2003|
|Primary Completion Date :||March 2010|
|Study Completion Date :||June 2010|
Active Comparator: TAC group
Oral tacrolimus (0.04-0.08 mg/kg/d) and prednisone for 12 months.
The calcineurin inhibitor is widely administered for organ transplantation，which establish the current method for lupus nephritis (LN).
20 patients with LN were self-assigned the therapy of TAC and prednisone for 12 months. The dosage was adjusted to achieve a whole blood TAC 12 h trough concentration.
Other Name: Prograf
Active Comparator: CYC group
Pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone followed by azathioprine (50mg/day）for 6 months.
20 patients with LN were self-assigned the protolcol of intravenous cyclophosphamide (750mg/m2 per month)/prednisone for six months followed by azathioprine(100mg/day)/prednisone for six months.
- Tacrolimus versus cyclophosphamide as treatment for diffuse proliferative or membranous lupus nephritis [ Time Frame: one year ]The primary study outcome measure was the cumulative rate of complete remission (CR).
- Evaluating the effective and safety of TAC for severe lupus nephritis compared CYC protocol. [ Time Frame: one year ]The secondary outcome measure were time required for CR, cumulative rate of sustained remission, relapse rate, immunological parameters, side effects, renal function during treatment and followed-up, and compliance with therapy and TAC dosing and serum levels.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207297
|Principal Investigator:||Jianghua Chen, MD||The First Affiliated Hospital, College of Medicine, Zhejiang University|