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Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)

Primary Purpose

Lupus Nephritis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multitherapy
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Tacrolimus, Mycophenolate mofetil, Cyclophosphamide, Lupus nephritis, Treatment

Eligibility Criteria

12 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female patients with a diagnosis of systemic lupus erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982, aged between 12-50 years, with score of SLE-DAI (Disease Active Index) of more than 12 (not including class V LN). Patients diagnosed according to ISN/RPS 2003 classification criteria: class Ⅲ, Ⅳ, Ⅳ + Ⅴ, Ⅲ + Ⅴ LN by renal biopsy within 3 months, CI< 4,Scr< 3 mg/dl. Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment. Patients who signed written informed consent forms (patients less than 18 years old with their parents/legal representative' signatures), and have given their consent to follow all study procedures and follow-ups. Exclusion Criteria: Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months. Patients with serum creatinine ≥ 3 mg/dl(265 μmol/L). Patients with severe infection or central nervous system symptoms. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis. Patients who have abnormal blood glucose, with a fasting blood glucose > 6.2 mmol/L or post meal blood glucose > 11.2 mmol/L. Patients who are pregnant or lactating. Patients who are known to be allergic to a macrolide.

Sites / Locations

  • Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
  • Research Institute of Nephrology, Jinling Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

FK506+MMF

Arm Description

Outcomes

Primary Outcome Measures

To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN

Secondary Outcome Measures

To investigate the safety and tolerability of FK506 combined with MMF versus intravenous CTX pulses

Full Information

First Posted
March 1, 2006
Last Updated
September 28, 2011
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00298506
Brief Title
Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)
Official Title
An Open, Prospective Study to Assess the Efficacy and Safety of FK506 Combined MMF in the Treatment of Class III,IV,V + IV or V + III Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506) combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.
Detailed Description
To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN. To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN. To explore the dosing of FK506 combined with MMF and their effective range of blood concentration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
Tacrolimus, Mycophenolate mofetil, Cyclophosphamide, Lupus nephritis, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FK506+MMF
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Multitherapy
Other Intervention Name(s)
FK506,Prograf,Tacrolimus, MMF,cellcept,mycophenolate mofetil
Intervention Description
Tacrolimus,4mg/d, MMF 1.0g/d
Primary Outcome Measure Information:
Title
To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN
Time Frame
18 months
Secondary Outcome Measure Information:
Title
To investigate the safety and tolerability of FK506 combined with MMF versus intravenous CTX pulses
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female patients with a diagnosis of systemic lupus erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982, aged between 12-50 years, with score of SLE-DAI (Disease Active Index) of more than 12 (not including class V LN). Patients diagnosed according to ISN/RPS 2003 classification criteria: class Ⅲ, Ⅳ, Ⅳ + Ⅴ, Ⅲ + Ⅴ LN by renal biopsy within 3 months, CI< 4,Scr< 3 mg/dl. Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment. Patients who signed written informed consent forms (patients less than 18 years old with their parents/legal representative' signatures), and have given their consent to follow all study procedures and follow-ups. Exclusion Criteria: Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months. Patients with serum creatinine ≥ 3 mg/dl(265 μmol/L). Patients with severe infection or central nervous system symptoms. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis. Patients who have abnormal blood glucose, with a fasting blood glucose > 6.2 mmol/L or post meal blood glucose > 11.2 mmol/L. Patients who are pregnant or lactating. Patients who are known to be allergic to a macrolide.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei-Shi Li, M.D.
Organizational Affiliation
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Research Institute of Nephrology, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
18596121
Citation
Bao H, Liu ZH, Xie HL, Hu WX, Zhang HT, Li LS. Successful treatment of class V+IV lupus nephritis with multitarget therapy. J Am Soc Nephrol. 2008 Oct;19(10):2001-10. doi: 10.1681/ASN.2007121272. Epub 2008 Jul 2.
Results Reference
derived

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Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)

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