Lupus NephritisPhase 2IGeLUNCT02936375
The Iguratimod Effect on Lupus Nephritis (IGeLU)
A Phase 2 study testing Iguratimod, Cyclophosphamide and Azathioprine in people with Lupus Nephritis, run by RenJi Hospital at 2 sites in China.
Trial summary
This study is a 52-week, randomized, open, active-controlled trial of patients with active diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic agent iguratimod. 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?
- Iguratimod, Cyclophosphamide and Azathioprine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 7 Sep 2017to Nov 2021
- Phase
- Phase 2
- 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
- Active lupus nephritis:
- Fulfill ACR classification criteria (2009) for SLE
- Proteinuria ≥1g/24h at screening
- Nephritis of class III, IV, V, III+IV or IV+V, confirmed by renal pathology within 90 days prior to screening
- Body weight ≥40kg
- SLE-2K score ≥8
- Agreement of contraception
- Informed consent obtained
Who cannot join
- Active severe SLE-driven renal disease or unstable renal disease at screening
- Active severe or unstable neuropsychiatric SLE
- Clinically significant active infection including ongoing and chronic infections
- History of receiving cyclophosphamide, azathioprine, tacrolimus , mycophenolate moetil or rituximab treatment with 90 days prior to screening
- History of human immunodeficiency virus (HIV)
- Confirmed Positive tests for hepatitis B or positive test for hepatitis C
Show all 11Show fewer
- Active tuberculosis
- Live or attenuated vaccine within 4 weeks prior to screening
- Subjects with significant hematologic abnormalities
- Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level
- History of peptic ulcer or GI bleeding; treatment with warfarin or other anticoagulants within last 14 days
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200001
Bao Chunde, MD, 021-63284622, baochunde_1678@yahoo.com.cn
Bao Chunde, MD
- Recruiting
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200065
Jianping Tang, MD, 86-21-56051080, tangjp6512@126.com
Jianping Tang, MD
About this study
Official title: The Effect of Iguratimod on Active Lupus Nephritis, the IGeLU Study: a Randomized Controlled Trial
This study is a 52-week, randomized, open, active-controlled trial of patients with active diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic agent iguratimod. The subjects will randomly receive iguratimod or cyclophosphamide followed with azathioprine, both combined with steroids.
- Conditions
- Lupus Nephritis
- Being tested
- Iguratimod, Cyclophosphamide, Azathioprine, Steroids
- Keywords
- lupus, nephritis, iguratimod
- Medical subject headings
- Lupus Nephritis, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
Also called T-614 (code name), Iremod (brand name)
25mg twice a day, orally administrated
CyclophosphamideDrug
1g/m², every 4 weeks, intravenous
AzathioprineDrug
2mg/kg·d, once a day, orally administrated
SteroidsDrug
Prednisone, methylprednisolone or prednisonlone, once a day, orally administrated. Steroids should be 1mg/kg·d in the beginning four weeks, then tapered 5-10mg/d every two weeks till 30mg/d, then tapered 2.5-5mg/d every two weeks. After 24 weeks of follow-up, a patient should receive steroids no more than 10mg/d. Patients may receive temporal high dose of steroids (1mg/kg·d) because of symptoms outside of kidney, for no more than two weeks. All the dosage of steroids above is calculated by prednisone.
| Study group | Role | What they receive |
|---|---|---|
| Iguratimod | Experimental | Patients will receive iguratimod over the whole follow-up, combined with steroids, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any) Receives: Drug: Iguratimod; Drug: Steroids |
| Cyc+AZA | Active comparator | Patients will receive cyclophosphamide in the first half of study (usually to 24 weeks), followed with azathioprine till the end of follow-up. Patients will also receive steroids as combinational therapy, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any) Receives: Drug: Cyclophosphamide; Drug: Azathioprine; Drug: Steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal remission rate
Measured: Week 52
Secondary outcomes (6)
Renal remission rate
Measured: Week 24
Renal flare rate
Measured: Week 52
Number of participants with treatment-related adverse events
adverse events are assessed by CTCAE v4.0
Measured: Week 52
SLEDAI-2K score
SLE SLE disease activity index (2000)
Measured: Week 52
BILAG score
British Isles lupus assessment group score
Measured: Week 52
PGA
Patient general assessment
Measured: Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start7 Sep 2017
- Primary completionNov 2020 (estimated)
- Study completionNov 2021 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunde Bao, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936375
- Sponsor's protocol ID
- [2016]128k
- Acronym
- IGeLU
- Status last verified
- Dec 2018
- First submitted
- 12 Oct 2016
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yan Q, Du F, Kang Y, Ye P, Wang X, Xu J, Tang J, Wang N, Jiang G, Li Z, Wang X, Xue Q, Huang X, Zhang X, Zhou Y, Dai M, Bao C. Comparison of iguratimod and conventional cyclophosphamide with sequential azathioprine as treatment of active lupus nephritis: study protocol for a multi-center, randomized, controlled clinical trial (iGeLU study). Trials. 2021 Aug 11;22(1):530. doi: 10.1186/s13063-021-05475-3.
PubMed 34380536
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Iguratimod on Active Lupus Nephritis, the IGeLU Study: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02936375
- Acronym / sponsor ID
- IGeLU / [2016]128k
- Conditions
- Lupus Nephritis
- Keywords
- lupus, nephritis, iguratimod
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 18 Oct 2016 (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 study is a 52-week, randomized, open, active-controlled trial of patients with active diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic agent iguratimod. The subjects will randomly receive iguratimod or cyclophosphamide followed with azathioprine, both combined with steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iguratimod | Experimental | Drug: Iguratimod, Drug: SteroidsPatients will receive iguratimod over the whole follow-up, combined with steroids, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any) |
| Cyc+AZA | Active comparator | Drug: Cyclophosphamide, Drug: Azathioprine, Drug: SteroidsPatients will receive cyclophosphamide in the first half of study (usually to 24 weeks), followed with azathioprine till the end of follow-up. Patients will also receive steroids as combinational therapy, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Active lupus nephritis:
- Body weight ≥40kg
- SLE-2K score ≥8
- Agreement of contraception
- Informed consent obtained
Key exclusion criteria (11 listed)
- Active severe SLE-driven renal disease or unstable renal disease at screening
- Active severe or unstable neuropsychiatric SLE
- Clinically significant active infection including ongoing and chronic infections
- History of receiving cyclophosphamide, azathioprine, tacrolimus , mycophenolate moetil or rituximab treatment with 90 days prior to screening
- History of human immunodeficiency virus (HIV)
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 |
|---|---|---|
| IguratimodAlso: T-614 (code name), Iremod (brand name)25mg twice a day, orally administrated | Drug | Iguratimod |
| Cyclophosphamide1g/m², every 4 weeks, intravenous | Drug | Cyc+AZA |
| Azathioprine2mg/kg·d, once a day, orally administrated | Drug | Cyc+AZA |
| SteroidsPrednisone, methylprednisolone or prednisonlone, once a day, orally administrated. Steroids should be 1mg/kg·d in the beginning four weeks, then tapered 5-10mg/d every two weeks till 30mg/d, then tapered 2.5-5mg/d every two weeks. After 24 weeks of follow-up, a patient should receive steroids no more than 10mg/d. Patients may receive temporal high dose of steroids (1mg/kg·d) because of symptoms outside of kidney, for no more than two weeks. All the dosage of steroids above is calculated by prednisone. | Drug | Cyc+AZA, Iguratimod |
Primary outcome
renal remission rate
Time frame: Week 52
6 secondary outcomes
Renal remission rate
Time frame: Week 24
Renal flare rate
Time frame: Week 52
Number of participants with treatment-related adverse events
Time frame: Week 52
SLEDAI-2K score
Time frame: Week 52
BILAG score
Time frame: Week 52
PGA
Time frame: Week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Derived from this study: PubMed 34380536Yan Q, Du F, Kang Y, Ye P, Wang X, Xu J, Tang J, Wang N, Jiang G, Li Z, Wang X, Xue Q, Huang X, Zhang X, Zhou Y, Dai M, Bao C. Comparison of iguratimod and conventional cyclophosphamide with sequential azathioprine as treatment of active lupus nephritis: study protocol for a multi-center, randomized, controlled clinical trial (iGeLU study). Trials. 2021 Aug 11;22(1):530. doi: 10.1186/s13063-021-05475-3.
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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.
Chunde Bao, MD principal investigator
RenJi Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iguratimod, Cyclophosphamide and Azathioprine in people with Lupus Nephritis, run by RenJi Hospital at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunde Bao, MD (86-21-63284622, baochunde_1678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal remission rate (time frame: Week 52). 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 NCT02936375, 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 19 Dec 2018.