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

NCT ID: NCT00298506

Last Updated: 2011-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-06-30

Brief Summary

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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

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1. 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.
2. 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.
3. To explore the dosing of FK506 combined with MMF and their effective range of blood concentration.

Conditions

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Lupus Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FK506+MMF

Group Type ACTIVE_COMPARATOR

Multitherapy

Intervention Type DRUG

Tacrolimus,4mg/d, MMF 1.0g/d

Interventions

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Multitherapy

Tacrolimus,4mg/d, MMF 1.0g/d

Intervention Type DRUG

Other Intervention Names

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FK506,Prograf,Tacrolimus MMF,cellcept,mycophenolate mofetil

Eligibility Criteria

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Inclusion Criteria

1. 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).
2. 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.
3. Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment.
4. 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

1. Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months.
2. Patients with serum creatinine ≥ 3 mg/dl（265 μmol/L).
3. Patients with severe infection or central nervous system symptoms.
4. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
5. Patients who have abnormal blood glucose, with a fasting blood glucose \> 6.2 mmol/L or post meal blood glucose \> 11.2 mmol/L.
6. Patients who are pregnant or lactating.
7. Patients who are known to be allergic to a macrolide.
Minimum Eligible Age

12 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zhi-Hong Liu, M.D.

Research Institute of Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lei-Shi Li, M.D.

Role: STUDY_DIRECTOR

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

Locations

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

Nanjing, Jiangsu, China

Site Status

Research Institute of Nephrology, Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 18596121 (View on PubMed)

Other Identifiers

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NJCT-0601

Identifier Type: -

Identifier Source: org_study_id