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The Iguratimod Effect on Lupus Nephritis (IGeLU) (IGeLU)

Primary Purpose

Lupus Nephritis

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Iguratimod

Cyclophosphamide

Azathioprine

Steroids

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring lupus, nephritis, iguratimod

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

RenJi HospitalRecruiting
Shanghai Tongji Hospital, Tongji University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iguratimod

Cyc+AZA

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

renal remission rate

Secondary Outcome Measures

Renal remission rate

Renal flare rate

Number of participants with treatment-related adverse events

adverse events are assessed by CTCAE v4.0

SLEDAI-2K score

SLE SLE disease activity index (2000)

BILAG score

British Isles lupus assessment group score

PGA

Patient general assessment

Full Information

NCT ID

NCT02936375

First Posted

October 12, 2016

Last Updated

December 18, 2018

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02936375

Brief Title

The Iguratimod Effect on Lupus Nephritis (IGeLU)

Acronym

IGeLU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 7, 2017 (Actual)

Primary Completion Date

November 2020 (Anticipated)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Nephritis

Keywords

lupus, nephritis, iguratimod

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iguratimod

Arm Type

Experimental

Arm Description

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)

Arm Title

Cyc+AZA

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Iguratimod

Other Intervention Name(s)

T-614 (code name), Iremod (brand name)

Intervention Description

25mg twice a day, orally administrated

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

1g/m², every 4 weeks, intravenous

Intervention Type

Drug

Intervention Name(s)

Azathioprine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Steroids

Intervention Description

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.

Primary Outcome Measure Information:

Title

renal remission rate

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Renal remission rate

Time Frame

Week 24

Title

Renal flare rate

Time Frame

Week 52

Title

Number of participants with treatment-related adverse events

Description

adverse events are assessed by CTCAE v4.0

Time Frame

Week 52

Title

SLEDAI-2K score

Description

SLE SLE disease activity index (2000)

Time Frame

Week 52

Title

BILAG score

Description

British Isles lupus assessment group score

Time Frame

Week 52

Title

PGA

Description

Patient general assessment

Time Frame

Week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chunde Bao, MD

Phone

86-21-63284622

baochunde_1678@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Qingran Yan, MD

Phone

86-21-53882280

YanQingran@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunde Bao, MD

Organizational Affiliation

RenJi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

RenJi Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bao Chunde, MD

Phone

021-63284622

baochunde_1678@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Bao Chunde, MD

First Name & Middle Initial & Last Name & Degree

Qingran Yan, MD

Facility Name

Shanghai Tongji Hospital, Tongji University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200065

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianping Tang, MD

Phone

86-21-56051080

tangjp6512@126.com

First Name & Middle Initial & Last Name & Degree

Jianping Tang, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34380536

Citation

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.

Results Reference

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The Iguratimod Effect on Lupus Nephritis (IGeLU)

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