Lupus NephritisPhase 3NCT01288664

Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis

A Phase 3 study testing ADVAGRAF in people with Lupus Nephritis, run by Sun Yat-sen University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V). Read more about this study

Who is it for?: Ages 14 to 65 years
Conditions the study is for: Lupus Nephritis
What is being tested?: ADVAGRAF
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteChina
Study dates: Jan 2011to Dec 2012
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 systemic lupus erythematosus (SLE) according to the albumin-creatinine ratio (ACR) criteria (1997);
Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class V, III +V, IV+V;
LN (Class IV+V): proteinuria > 1g/24hr or Scr > 1.3 mg/dl or active urinary sediment (erythrocyte cast, > 5 white blood cell count (WBC) /high power field (hpf)(excluding infection ), > 5 red blood cell count (RBC)/hpf;
LN (Class V or III +V ): proteinuria > 2g/24hr or Scr > 1.3 mg/dl;
Provision of written informed consent by subject or guardian

Who cannot join

Inability or unwillingness to provide written informed consent
Usage of immunosuppression therapy (MMF, Cyclophosphamide (CTX), Cyclosporine A (CysA), methotrexate (MTX) ect) for more than 1 week within 1 month or Pulse intravenous MP treatment prior to recruitment
Scr > 4mg/dl (354umol/L)
Needing pulse intravenous Methylprednisolone (MP) or intravenous immunoglobulin
Lupus encephalopathy
Diagnosed diabetes mellitus (DM); Malignant tumors (except fully cured basal cell carcinoma)

Show all 12Show fewer

History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study
Any Active systemic infection or history of serious infection within one month of entry
known infection with HIV, hepatitis B, or hepatitis C
Known hypersensitivity or contraindication to tacrolimus, corticosteroids
Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening
Pregnancy, nursing or use of a non-reliable method of contraception.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080

Other trials in China

About this study

This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V).

Conditions: Lupus Nephritis
Being tested: ADVAGRAF
Keywords: Lupus Nephritis, Tacrolimus, Induction Phase
Medical subject headings: Lupus Nephritis

What participants receive

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

ADVAGRAFDrug
Also called ADVAGRAF:Tacrolimus Sustained-release Capsules
Tacrolimus Sustained-release Capsules (ADVAGRAF) Started: 0.05-0.1mg/kg/d, one time per day, the blood level:5-10ng/ml in induction phase.

Study groups in NCT01288664
Study group	Role	What they receive
ADVAGRAF	Experimental	Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase for 6 months Receives: Drug: ADVAGRAF

What is being measured

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

Remission rate (complete or partial remission)
Measured: 6 months

Secondary outcomes (5)

proteinuria
Measured: every 3 months,up to 6 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores
SLEDAI (Systemic Lupus Erythematosus Disease Activity Index, Bombardier et al, 1992).
Measured: every 3 months, up to 6 months
Number of participants with adverse events as a measure of safety and tolerability
Adverse events,including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc.
Measured: every 3 months, up to 6 months
renal function
Measured: every 3 months, up to 6 months
relapse
Measured: every 3 months, up to 6 months

Timeline

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

Jan 2011Dec 2012

First posted2 Feb 2011 (estimated)
Study startJan 2011
Primary completionDec 2012 (estimated)
Study completionDec 2012 (estimated)

Why it stopped: sponsor withdraw from this study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lupus NephritisStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01288664
Sponsor's protocol ID: SYSU-PRGLN-002
Status last verified: Dec 2013
First submitted: 1 Feb 2011
Last updated: 12 Feb 2014
Results posted: No
Data monitoring committee: Yes

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

RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis

All Lupus Nephritis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis
ClinicalTrials.gov ID: NCT01288664
Acronym / sponsor ID: SYSU-PRGLN-002
Conditions: Lupus Nephritis
Keywords: Lupus Nephritis, Tacrolimus, Induction Phase
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: sponsor withdraw from this study
Enrolment: 0 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: Jan 2011
Primary completion: Dec 2012 (estimated)
Study completion: Dec 2012 (estimated)
First posted: 2 Feb 2011 (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.

This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ADVAGRAF	Experimental	Drug: ADVAGRAFTacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase for 6 months

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 systemic lupus erythematosus (SLE) according to the albumin-creatinine ratio (ACR) criteria (1997);
Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class V, III +V, IV+V;
LN (Class IV+V): proteinuria > 1g/24hr or Scr > 1.3 mg/dl or active urinary sediment (erythrocyte cast, > 5 white blood cell count (WBC) /high power field (hpf)(excluding infection ), > 5 red blood cell count (RBC)/hpf;
LN (Class V or III +V ): proteinuria > 2g/24hr or Scr > 1.3 mg/dl;

Key exclusion criteria (12 listed)

Inability or unwillingness to provide written informed consent
Usage of immunosuppression therapy (MMF, Cyclophosphamide (CTX), Cyclosporine A (CysA), methotrexate (MTX) ect) for more than 1 week within 1 month or Pulse intravenous MP treatment prior to recruitment
Scr > 4mg/dl (354umol/L)
Needing pulse intravenous Methylprednisolone (MP) or intravenous immunoglobulin
Lupus encephalopathy

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
ADVAGRAFAlso: ADVAGRAF:Tacrolimus Sustained-release CapsulesTacrolimus Sustained-release Capsules (ADVAGRAF) Started: 0.05-0.1mg/kg/d, one time per day, the blood level:5-10ng/ml in induction phase.	Drug	ADVAGRAF

Primary outcome

Remission rate (complete or partial remission)
Time frame: 6 months

5 secondary outcomes

proteinuria
Time frame: every 3 months,up to 6 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores
Time frame: every 3 months, up to 6 months
Number of participants with adverse events as a measure of safety and tolerability
Time frame: every 3 months, up to 6 months
renal function
Time frame: every 3 months, up to 6 months
relapse
Time frame: every 3 months, up to 6 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.

Related trials for Lupus Nephritis

RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis

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.

Yu Xueqing, MD principal investigator

Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen 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 ADVAGRAF in people with 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 12 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: withdrawn, as of the sponsor's last update on 12 Feb 2014. 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 was withdrawn before enrolling participants, so there are no results.

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 (complete or partial remission) (time frame: 6 months). 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 NCT01288664.

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 12 Feb 2014.