A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
- Conditions
- IgA Nephropathy
- Registration Number
- JPRN-jRCT2080223899
- Lead Sponsor
- Merck Biopharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 60
1.Male or female of over 20 years of age
2.Renal biopsy report documenting IgAN
3.UPCR > 0.75 mg/mg by 24-hour urine collection during the Screening Period with at least one documented historical UPCR > 1 mg/mg within 12 months prior to the Screening visit while on 4.ACEi and/or ARB therapy, or UPCR > 1 mg/mg by 24-hour urine collection during the Screening Period
4.Initiation of ACEi and/or ARB at least 12 weeks prior to the Screening Visit. The dose of ACEi and/or ARB must be stable for at least 8 weeks prior to the Screening Visit
1.Concomitant significant renal disease other than IgAN (eg, diabetic nephropathy, lupus nephritis, minimal change disease)
2.On kidney biopsy, more than 50percent glomeruli with global glomerulosclerosis, or more than 50percent of cortical area involved by tubular atrophy or interstitial fibrosis
3.Diagnosis of Henoch-Schonlein purpura
4.Renal or other organ transplantation prior to, or expected during, the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method