Nephritis, LupusPhase 3NCT01328834
Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis
A Phase 3 study testing Tacrolimus Sustained-release Capsules (ADVAGRAF) in people with Nephritis, Lupus, run by Sun Yat-sen University at 1 site in China.
Trial summary
This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN). Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Nephritis, Lupus
- What is being tested?
- Tacrolimus Sustained-release Capsules (ADVAGRAF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Oct 2011
- 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 study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class IV, V, V+ III, V+ IV;
- Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months;
- proteinuria > 1g/24hr or Scr > 1.3 mg/dl or active urinary sediment (erythrocyte cast, > 5 WBC/high power field (hpf) (excluding infection), > 5 RBC/hpf);
- 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, CTX, CysA, MTX etc) for more than 1 week within 1 month or intravenous MP Pulse treatment prior to entry;
- Scr > 4mg/dl (354umol/L);
- Needing pulse intravenous MP or intravenous immunoglobulin;
- Lupus encephalopathy;
- Diagnosed DM; Malignant tumors (except fully cured basal cell carcinoma);
Show all 11Show fewer
- History of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study;
- Known hypersensitivity or contraindication to tacrolimus, corticosteroids
- Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C;
- 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 IRB
Guangzhou, Guangdong, 510080
About this study
This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).
- Conditions
- Nephritis, Lupus
- Being tested
- Tacrolimus Sustained-release Capsules (ADVAGRAF)
- Keywords
- Nephritis, Lupus, Tacrolimus
- 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 Sustained-release Capsules (ADVAGRAF)Drug
Also called ADVAGRAF: Tacrolimus Sustained-release Capsules
Started: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment.
| Study group | Role | What they receive |
|---|---|---|
| ADVAGRAF | Experimental | Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase Receives: Drug: Tacrolimus Sustained-release Capsules (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 after therapy
Secondary outcomes (5)
The changes of proteinuria
Measured: every 3 months up to 6 months
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
The changes of 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.
- First posted5 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephritis, LupusStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Yu Xueqing, MD, Principal investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328834
- Sponsor's protocol ID
- SYSU-PRGLN-003
- Status last verified
- Oct 2011
- First submitted
- 1 Feb 2011
- Last updated
- 3 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. 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 Treatment in Refractory Lupus Nephritis
- ClinicalTrials.gov ID
- NCT01328834
- Acronym / sponsor ID
- SYSU-PRGLN-003
- Conditions
- Nephritis, Lupus
- Keywords
- Nephritis, Lupus, Tacrolimus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Apr 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 a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).
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: Tacrolimus Sustained-release Capsules (ADVAGRAF)Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction 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 study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class IV, V, V+ III, V+ IV;
- Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months;
- proteinuria > 1g/24hr or Scr > 1.3 mg/dl or active urinary sediment (erythrocyte cast, > 5 WBC/high power field (hpf) (excluding infection), > 5 RBC/hpf);
Key exclusion criteria (11 listed)
- Inability or unwillingness to provide written informed consent ;
- Usage of immunosuppression therapy (MMF, CTX, CysA, MTX etc) for more than 1 week within 1 month or intravenous MP Pulse treatment prior to entry;
- Scr > 4mg/dl (354umol/L);
- Needing pulse intravenous 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 |
|---|---|---|
| Tacrolimus Sustained-release Capsules (ADVAGRAF)Also: ADVAGRAF: Tacrolimus Sustained-release CapsulesStarted: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment. | Drug | ADVAGRAF |
Primary outcome
Remission rate (complete or partial remission)
Time frame: 6 months after therapy
5 secondary outcomes
The changes of proteinuria
Time frame: every 3 months up to 6 months
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
The changes of 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 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 3 Nov 2011.
Related trials for Nephritis, Lupus
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 Tacrolimus Sustained-release Capsules (ADVAGRAF) in people with Nephritis, Lupus, 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 11 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 3 Nov 2011. 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 (complete or partial remission) (time frame: 6 months after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2011.