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CompletedNCT00876616Updated Aug 29, 2013

Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis

An interventional study of Tacrolimus+Mycophenolate mofetil and Cyclophosphamide in Lupus Nephritis, sponsored by Zhi-Hong Liu, M.D.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-08-29.

Sponsored by Zhi-Hong Liu, M.D. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
362
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to assess the efficacy and safety of multi-target therapy in the treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ lupus nephritis.

Read the detailed description
  1. To assess the efficacy of FK506 combined with MMF vs intravenous cyclophosphamide (CTX) pulses in treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ Lupus Nephritis (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,Ⅲ+Ⅴand Ⅳ+Ⅴ LN.
02

Conditions studied

  • Lupus Nephritis

Keywords

  • lupus nephritis;multi-target therapy; MMF; FK506
03

In context

Nephritis

245 studies on the registry are indexed under Nephritis; 56 are open to participants now.

This study's enrollment of 362 is above the median of 49 across 156 interventional studies indexed under Nephritis.

Browse Nephritis studies →

Lead sponsor

Zhi-Hong Liu, M.D. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Written informed consent by subject or guardian
  2. 18 to 65 years of age (inclusive 18 and 65), male or female
  3. Diagnosis of SLE according to the American College of Rheumatology criteria (1997)
  4. Diagnosis of Class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+ⅤLN according to the ISN/RPS 2003 classification by light, immunofluorescence, and electron microscopy within 6 months before enrollment
  5. Pathologic chronic index (CI) ≤3' without thrombotic microangiopathy (TMA)
  6. SLE Disease Activity Index (DAI) >10'
  7. Proteinuria ≥1.5g/d,with or without active urinary sediment
  8. Serum creatinine (Scr)≤3.0mg/dl (265.2 mol/L)

Exclusion criteria

Exclusion Criteria:

  1. Previous treatment with MMF, CTX, tacrolimus, Cyclosporin A (CsA), large doses of immunoglobulin and methylprednisolone (MP), plasmapheresis or renal replacement therapy within the past 12 weeks. Oral glucocorticoids, azathioprine, intravenous MP (≤80mg/d), short-time CsA (\<2 weeks) or leflunomide (\<4 weeks) are allowed
  2. ALT or AST increase twice above the upper limit of the normal range
  3. Hyperglycemia is defined as fasting blood glucose level ≥7.0 mmol/L and/or postprandial blood sugar level>11.1 mmol/L
  4. Known hypersensitivity or contraindication to any components of MMF, tacrolimus, CTX or glucocorticoids
  5. History of present illness:

    1. active HBV infection (HBsAg, HBeAg and anti-HBc positive or HBsAg, anti- HBe and anti-HBc positive), HCV infection, pulmonary tuberculosis, cytomegalovirus(CMV) infection (defined as CMV-IgM positive or CMV-DNA positive), fungal infection or HIV infection, within 3 months before the enrollment
    2. non-healed active peptic ulcer within 3 months before the enrollment
    3. drug or drinking abuse
    4. malnutrition (BMI \<18.5kg/m2) or body weight \<50Kg
  6. Other active diseases, such as:

    1. severe cardiovascular diseases
    2. chronic obstructive pulmonary disease(COPD)or asthma requiring oral glucocorticoids
    3. marrow depression not due to SLE activation: white blood cell count \<3000/mm3 or neutrophil count \<1300/mm3 or platelet count \<50000/mm3
  7. Severe infection or need of antibiotic therapy
  8. Female patients who are pregnant/breastfeeding or those patients (both gender) who refused contraception
  9. Life-threatening complications such as large hydropericardium, pneumohemorrhagia, lupus encephalopathy and severe pulmonary hypertension or patients in need of MP pulse (>0.5g/d ) treatment because of aggravation of SLE
  10. Known to be non-compliance or violation of the protocol base on investigator's judgement
  11. Patient who participate of any other investigational drug study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
362 participants (actual)

Study arms

  • Experimental
    Tacrolimus+Mycophenolate mofetil

    FK506 4mg/d+MMF 1.0g/d

    Drug: Tacrolimus+Mycophenolate mofetil

  • Active comparator
    Cyclophosphamide

    CTX iv 0.75 g/m2 body surface area (BSA)

    Drug: Cyclophosphamide

Interventions

  • DrugTacrolimus+Mycophenolate mofetil

    FK506 4mg/d,MMF 1.0g/d

    Also known as: FK506+MMF

  • DrugCyclophosphamide

    CTX 0.75g/m2 BSA

    Also known as: CTX

06

What researchers measure

Primary outcomes

  1. To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ,Ⅴ, Ⅲ+Ⅴand Ⅳ+Ⅴ LN.

    The primary endpoint is the rate of complete remission at 24 weeks.

    Time frame: 24 weeks

Secondary outcomes

  1. To investigate the other efficacy indicators of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ,Ⅴ, Ⅲ+Ⅴand Ⅳ+Ⅴ LN.

    The secondary endpoints include total remission, time to complete remission and remission, rate of complete remission and remission in patients with different types of LN, changes between baseline and after 24 week of induction treatment in proteinuria, albumin, SCr, eGFR, complement, autoantibodies, SLE-DAI and dosage and concentration of immunosuppressants between groups.

    Time frame: 24 weeks

Other outcomes

  1. To assess the Safety of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ,Ⅴ, Ⅲ+Ⅴand Ⅳ+Ⅴ LN.

    Safety assessments include clinical manifestations, physical examination, laboratory tests laboratory tests (including hematology, serum chemistry, urinalysis), adverse events (including gastrointestinal toxicity and severe infections requiring antibiotics treatment) and concomitant medications.

    Time frame: 24 weeks

07

Study locations

1 site
  • Research Institute of Nephrology,Jinling Hospital
    Nanjing, Jiangsu 210002, China
08

References and documents

Publications

  • Liu Z, Zhang H, Liu Z, Xing C, Fu P, Ni Z, Chen J, Lin H, Liu F, He Y, He Y, Miao L, Chen N, Li Y, Gu Y, Shi W, Hu W, Liu Z, Bao H, Zeng C, Zhou M. Multitarget therapy for induction treatment of lupus nephritis: a randomized trial. Ann Intern Med. 2015 Jan 6;162(1):18-26. doi: 10.7326/M14-1030. PubMed 25383558 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00876616
Lead sponsor
Zhi-Hong Liu, M.D.
Collaborators
Ruijin Hospital, West China Hospital, RenJi Hospital, China Medical University, China, Huashan Hospital, The First Affiliated Hospital with Nanjing Medical University, Beijing Friendship Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Zhi-Hong Liu, M.D. (professor, Nanjing University School of Medicine) — Sponsor-investigator
First posted
Apr 7, 2009
Start date
Apr 2009
Primary completion
May 2011
Completion
Feb 2012
Last update
Aug 29, 2013

Study contacts

Zhihong Liu, Master
principal investigator · Nanjing University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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