Lupus NephritisNCT00876616
Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis
A study testing Tacrolimus+Mycophenolate mofetil and Cyclophosphamide in people with Lupus Nephritis, run by Zhi-Hong Liu, M.D. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Tacrolimus+Mycophenolate mofetil and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent by subject or guardian
- 18 to 65 years of age (inclusive 18 and 65), male or female
- Diagnosis of SLE according to the American College of Rheumatology criteria (1997)
- 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
- Pathologic chronic index (CI) ≤3' without thrombotic microangiopathy (TMA)
- SLE Disease Activity Index (DAI) >10'
- Proteinuria ≥1.5g/d，with or without active urinary sediment
- Serum creatinine (Scr)≤3.0mg/dl (265.2 mol/L)
Who cannot join
- 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
- ALT or AST increase twice above the upper limit of the normal range
- Hyperglycemia is defined as fasting blood glucose level ≥7.0 mmol/L and/or postprandial blood sugar level>11.1 mmol/L
- Known hypersensitivity or contraindication to any components of MMF, tacrolimus, CTX or glucocorticoids
- History of present illness:
- 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
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- non-healed active peptic ulcer within 3 months before the enrollment
- drug or drinking abuse
- malnutrition (BMI <18.5kg/m2) or body weight <50Kg
- Other active diseases, such as:
- severe cardiovascular diseases
- chronic obstructive pulmonary disease(COPD)or asthma requiring oral glucocorticoids
- marrow depression not due to SLE activation: white blood cell count <3000/mm3 or neutrophil count <1300/mm3 or platelet count <50000/mm3
- Severe infection or need of antibiotic therapy
- Female patients who are pregnant/breastfeeding or those patients (both gender) who refused contraception
- 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
- Known to be non-compliance or violation of the protocol base on investigator's judgement
- Patient who participate of any other investigational drug study.
Trial locations and contacts
1 site in 1 country.
China1 site
Research Institute of Nephrology,Jinling Hospital
Nanjing, Jiangsu, 210002
About this study
Official title: An Multi-site, Open, Prospective Study to Assess the Efficacy and Safety of Multi-target Therapy in the Treatment of Class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ Lupus Nephritis
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
- 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).
- 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.
- Conditions
- Lupus Nephritis
- Being tested
- Tacrolimus+Mycophenolate mofetil, Cyclophosphamide
- Keywords
- lupus nephritis;multi-target therapy; MMF; FK506
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus+Mycophenolate mofetilDrug
Also called FK506+MMF
FK506 4mg/d,MMF 1.0g/d
CyclophosphamideDrug
Also called CTX
CTX 0.75g/m2 BSA
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus+Mycophenolate mofetil | Experimental | FK506 4mg/d+MMF 1.0g/d Receives: Drug: Tacrolimus+Mycophenolate mofetil |
| Cyclophosphamide | Active comparator | CTX iv 0.75 g/m2 body surface area (BSA) Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhi-Hong Liu, M.D.
- Sponsor type
- University, hospital or other
- 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
- Sponsor-investigator, Zhi-Hong Liu, M.D., Nanjing University School of Medicine
- Investigators
- Zhihong Liu, Master, Principal investigator, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876616
- Sponsor's protocol ID
- NJCT-0901
- Status last verified
- Aug 2013
- First submitted
- 6 Apr 2009
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Multi-site, Open, Prospective Study to Assess the Efficacy and Safety of Multi-target Therapy in the Treatment of Class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ Lupus Nephritis
- ClinicalTrials.gov ID
- NCT00876616
- Acronym / sponsor ID
- NJCT-0901
- Conditions
- Lupus Nephritis
- Keywords
- lupus nephritis;multi-target therapy; MMF; FK506
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Zhi-Hong Liu, M.D.University, hospital or other
- 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
- Study start
- Apr 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus+Mycophenolate mofetil | Experimental | Drug: Tacrolimus+Mycophenolate mofetilFK506 4mg/d+MMF 1.0g/d |
| Cyclophosphamide | Active comparator | Drug: CyclophosphamideCTX iv 0.75 g/m2 body surface area (BSA) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent by subject or guardian
- 18 to 65 years of age (inclusive 18 and 65), male or female
- Diagnosis of SLE according to the American College of Rheumatology criteria (1997)
- 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
- Pathologic chronic index (CI) ≤3' without thrombotic microangiopathy (TMA)
Key exclusion criteria (18 listed)
- 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
- ALT or AST increase twice above the upper limit of the normal range
- Hyperglycemia is defined as fasting blood glucose level ≥7.0 mmol/L and/or postprandial blood sugar level>11.1 mmol/L
- Known hypersensitivity or contraindication to any components of MMF, tacrolimus, CTX or glucocorticoids
- History of present illness:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus+Mycophenolate mofetilAlso: FK506+MMFFK506 4mg/d,MMF 1.0g/d | Drug | Tacrolimus+Mycophenolate mofetil |
| CyclophosphamideAlso: CTXCTX 0.75g/m2 BSA | Drug | Cyclophosphamide |
Primary outcome
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.
Time frame: 24 weeks
The primary endpoint is the rate of complete remission at 24 weeks.
1 secondary outcome
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.
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
- Derived from this study: PubMed 25383558Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhihong Liu, Master principal investigator
Nanjing University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tacrolimus+Mycophenolate mofetil and Cyclophosphamide in people with Lupus Nephritis, run by Zhi-Hong Liu, M.D. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2013.