Kidney DiseasesPhase 3NCT00615173

Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis

A Phase 3 study testing tacrolimus (FK506) and cyclophosphamide or azathioprine in people with Kidney Diseases and Lupus Nephritis, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V). To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V). Read more about this study

Who is it for?: Ages 14 to 65 years
Conditions the study is for: Kidney Diseases, Lupus Nephritis, Tacrolimus
What is being tested?: tacrolimus (FK506) and cyclophosphamide or azathioprine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteChina
Study dates: Jul 2006to Sep 2008
Phase: Phase 3
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 14 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects of either sex, 14-65 years of age;
Diagnosis of SLE according to the ACR criteria(1997);
Kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V;
Class IV LN: proteinuria >1g/24hr or Scr>115umol/L;
Class III or V LN: proteinuria >2g/24hr or Scr>115umol/L;
Provision of written informed consent by subject or guardian.

Who cannot join

Inability or unwillingness to provide written informed consent ;
Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
Pregnancy, nursing or use of a non-reliable method of contraception;
Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
Previous kidney transplant or planted transplant;

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Scr > 4mg/dl (353umol/L);
Active hepatitis, with liver dysfunction;
Diagnosed DM;
Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .

Trial locations and contacts

1 site in 1 country.

China1 site

The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, 510080

Other trials in China

About this study

The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V).

To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V).

Conditions: Kidney Diseases, Lupus Nephritis, Tacrolimus, Induction Phase, Maintenance Phase
Being tested: tacrolimus (FK506), cyclophosphamide or azathioprine
Keywords: Tacrolimus, lupus nephritis
Medical subject headings: Kidney Diseases, Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tacrolimus (FK506)Drug
Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;
cyclophosphamide or azathioprineDrug
Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.

Study groups in NCT00615173
Study group	Role	What they receive
1	Experimental	tacrolimus(fk506) treatment in induction and maintenance phase Receives: Drug: tacrolimus (FK506)
2	Active comparator	intravenous cyclophosphamide pulses treatment in induction phase; and Aza in the maintenance phase Receives: Drug: cyclophosphamide or azathioprine

What is being measured

The primary outcome is the main question the study is designed to answer.

Remission rate
Measured: 2006-2008

Secondary outcomes (1)

Renal function, proteinuria, relapse.
Measured: 2006-2008

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2006Sep 2008

First posted14 Feb 2008 (estimated)
Study startJul 2006
Primary completionSep 2008
Study completionSep 2008

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 Kidney DiseasesStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00615173
Sponsor's protocol ID: SYSU-PRGLN-001
Status last verified: Oct 2008
First submitted: 1 Feb 2008
Last updated: 29 Oct 2008
Results posted: No
Data monitoring committee: Yes

Publications

Chen W, Tang X, Liu Q, Chen W, Fu P, Liu F, Liao Y, Yang Z, Zhang J, Chen J, Lou T, Fu J, Kong Y, Liu Z, Fan A, Rao S, Li Z, Yu X. Short-term outcomes of induction therapy with tacrolimus versus cyclophosphamide for active lupus nephritis: A multicenter randomized clinical trial. Am J Kidney Dis. 2011 Feb;57(2):235-44. doi: 10.1053/j.ajkd.2010.08.036. Epub 2010 Dec 21.
PubMed 21177013

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Kidney Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis
ClinicalTrials.gov ID: NCT00615173
Acronym / sponsor ID: SYSU-PRGLN-001
Conditions: Kidney Diseases, Lupus Nephritis, Tacrolimus, Induction Phase, Maintenance Phase
Keywords: Tacrolimus, lupus nephritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: Jul 2006
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 14 Feb 2008 (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 compare the efficacy and safety of tacrolimus vs intravenous cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V).

To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: tacrolimus (FK506)tacrolimus(fk506) treatment in induction and maintenance phase
2	Active comparator	Drug: cyclophosphamide or azathioprineintravenous cyclophosphamide pulses treatment in induction phase; and Aza in the maintenance phase

Who may qualify

Ages: 14 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Subjects of either sex, 14-65 years of age;
Diagnosis of SLE according to the ACR criteria(1997);
Kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V;
Class IV LN: proteinuria >1g/24hr or Scr>115umol/L;
Class III or V LN: proteinuria >2g/24hr or Scr>115umol/L;

Key exclusion criteria (10 listed)

Inability or unwillingness to provide written informed consent ;
Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
Pregnancy, nursing or use of a non-reliable method of contraception;
Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;

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 (FK506)Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;	Drug	1
cyclophosphamide or azathioprineInduction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.	Drug	2

Primary outcome

Remission rate
Time frame: 2006-2008

1 secondary outcome

Renal function, proteinuria, relapse.
Time frame: 2006-2008

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 Oct 2008.
Derived from this study: PubMed 21177013Chen W, Tang X, Liu Q, Chen W, Fu P, Liu F, Liao Y, Yang Z, Zhang J, Chen J, Lou T, Fu J, Kong Y, Liu Z, Fan A, Rao S, Li Z, Yu X. Short-term outcomes of induction therapy with tacrolimus versus cyclophosphamide for active lupus nephritis: A multicenter randomized clinical trial. Am J Kidney Dis. 2011 Feb;57(2):235-44. doi: 10.1053/j.ajkd.2010.08.036. Epub 2010 Dec 21.

Related trials for Kidney Diseases

Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease

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.

Xue Qing Yu, MD principal investigator

Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Ping Fu, MD principal investigator

Department of Nephrology, West China Hospital of Sichuan University

Yun Hua Liao, MD principal investigator

Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tacrolimus (FK506) and cyclophosphamide or azathioprine in people with Kidney Diseases and Lupus Nephritis, run by Sun Yat-sen University 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 6 inclusion and 10 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 Oct 2008. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Remission rate (time frame: 2006-2008). 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 NCT00615173, 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 Oct 2008.