Clinical Trials List
2020-08-27 - 2023-12-18
Phase II
Recruiting4
ICD-10E10.21
Type 1 diabetes mellitus with diabetic nephropathy
ICD-10E11.21
Type 2 diabetes mellitus with diabetic nephropathy
ICD-10N16
Renal tubulo-interstitial disorders in diseases classified elsewhere
ICD-9583.81
Nephritis and nephropathy, not specified as acute or chronic, in diseases classified elsewhere
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects With Active Lupus Nephritis
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Trial Applicant
Johnson & Johnson
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Sponsor
Janssen Research & Development, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 陳彥輔 風濕免疫科
- Chen-I Hsieh 風濕免疫科
- Ping-Han Tsai 風濕免疫科
- 張哲慈 風濕免疫科
- Chang-Fu Kuo 風濕免疫科
- Yun Chen Tsai 風濕免疫科
- TianMing Zhan 風濕免疫科
- Yao-Fan Fang 風濕免疫科
- Yun Ju Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃建中 風濕免疫科
- Chen Der-Yuan 風濕免疫科
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- CHENG-HAN WU 風濕免疫科
- SONG-CHOU HSIEH 風濕免疫科
- 呂政勳 風濕免疫科
- KO-JEN LI 風濕免疫科
- 郭佑民 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Percentage of Participants Achieving at Least 50 Percentage (%) Decrease in Proteinuria [ Time Frame: Baseline and Week 24 ]
Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 24 will be reported.
Inclution Criteria
Currently receiving prednisone equivalent dose of 1 milligram per kilogram per day (mg/kg/day) or less than or equal to (<=) 60 mg/day, whichever is lower, or less. Must be receiving prednisone equivalent of 10 mg/day or more at screening and randomization. Treated for greater than or equal to (>=) 6 weeks with stable dosing >=2 weeks before randomization
If receiving angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blockers (ARB), a stable dose for at least 2 weeks prior to randomization
Positive antinuclear antibody (ANA; >= 1:80 titer by central laboratory test) or positive anti-double-stranded deoxyribonucleic acid (dsDNA) test results at screening
Kidney biopsy documentation of International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III-IV within the last 6 months prior to screening or performed during screening
Urine Protein to Creatinine Ratio (UPCR) >= 1.0 milligram/milligram (mg/mg) assessed on 2 first morning urine void specimens during screening. These 2 specimens do not need to be on consecutive days, however, 2 samples must be tested with UPCR >= 1.0 mg/mg in a row. The UPCR requirement must be met after at least 8 weeks of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) treatment, and after stable glucocorticoid dosing is achieved at the dose intended at time of randomization
Exclusion Criteria
Comorbidities (other than lupus nephritis [LN], example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months
Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease
Received PO (orally) cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to randomization
History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
History of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening
The Estimated Number of Participants
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Taiwan
6 participants
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Global
60 participants
