The Iguratimod Effect on Lupus Nephritis (IGeLU)

NCT02936375 — Phase 2, Unknown, 120 participants, RenJi Hospital

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The Effect of Iguratimod on Active Lupus Nephritis, the IGeLU Study: a Randomized Controlled Trial

Registry	NCT02936375, acronym IGeLU
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	120 (Estimated)
Sponsor	RenJi Hospital (Other)
Conditions	Lupus Nephritis
Interventions	Iguratimod, Cyclophosphamide, Azathioprine, Steroids (Drug)
Dates	start 2017-09-07, primary completion 2020-11-01 (estimated), completion 2021-11-01 (estimated), first posted 2016-10-18, last updated 2018-12-19
Locations	2 sites in China

-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. The subjects will randomly receive iguratimod or cyclophosphamide followed with azathioprine, both combined with steroids.

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+Arms and interventions

Arm	Type	Interventions	Description
Iguratimod	Experimental	Drug: Iguratimod; Drug: Steroids	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)
Cyc+AZA	Active comparator	Drug: Cyclophosphamide; Drug: Azathioprine; Drug: Steroids	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)

Iguratimod (Drug), also known as T-614 (code name), Iremod (brand name): 25mg twice a day, orally administrated
Cyclophosphamide (Drug): 1g/m², every 4 weeks, intravenous
Azathioprine (Drug): 2mg/kg·d, once a day, orally administrated
Steroids (Drug): 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.

+Outcome measures

Primary outcomes

renal remission rate [Week 52]

Secondary outcomes

Renal remission rate [Week 24]
Renal flare rate [Week 52]
Number of participants with treatment-related adverse events [Week 52]: adverse events are assessed by CTCAE v4.0
SLEDAI-2K score [Week 52]: SLE SLE disease activity index (2000)
BILAG score [Week 52]: British Isles lupus assessment group score
PGA [Week]: Patient general assessment

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

+Locations (2)

Facility	City	Country	Status
RenJi Hospital	Shanghai, Shanghai Municipality	China	Recruiting
Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai, Shanghai Municipality	China	Recruiting

+Publications

Results publication: 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. PMID 34380536

+Investigators

Chunde Bao, MD, Principal investigator, RenJi Hospital