The Iguratimod Effect on Lupus Nephritis (IGeLU)

Sponsor

RenJi Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02936375

Collaborator

(none)

120

Enrollment

Locations

Arms

49.8

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Drug: Iguratimod Drug: Cyclophosphamide Drug: Azathioprine Drug: Steroids	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 7, 2017

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iguratimod 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)	Drug: Iguratimod 25mg twice a day, orally administrated Other Names: T-614 (code name) Iremod (brand name) Drug: Steroids 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.
Active Comparator: Cyc+AZA 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)	Drug: Cyclophosphamide 1g/m², every 4 weeks, intravenous Drug: Azathioprine 2mg/kg·d, once a day, orally administrated Drug: Steroids 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.

Arm

Intervention/Treatment

Experimental: Iguratimod

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)

Drug: Iguratimod

25mg twice a day, orally administrated

Other Names:

T-614 (code name)

Iremod (brand name)

Drug: Steroids

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.

Active Comparator: Cyc+AZA

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)

Drug: Cyclophosphamide

1g/m², every 4 weeks, intravenous

Drug: Azathioprine

2mg/kg·d, once a day, orally administrated

Drug: Steroids

Outcome Measures

Primary Outcome Measures

renal remission rate [Week 52]

Secondary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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