A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223899

Enrollment

Registered

2018-05-14

Start date

2017-02-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

Interventions

investigational material(s) Generic name etc : Atacicept25mg INN of investigational material : Atacicept Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
safety efficacy Evaluate the safety and tolerability profiles of atacicept in subjects with IgA Nephropathy (IgAN) and persistent proteinuria (ie, urine protein to creatinine ratio [UPCR] or more 1 mg/mg) through Week 48, while on a stable dose of angiotensin converting enzyme inhibitor (ACEi) and/ or angiotensin receptor Blockers (ARB), considered optimal by the Investigator.	—

Secondary

Measure	Time frame
safety efficacy Evaluate the pharmacodynamic (PD) effect of atacicept Evaluate the serum atacicept concentrations (pharmacokinetic [PK]) Evaluate the safety and tolerability profiles of atacicept Evaluate the immunogenicity profile of atacicept	—

Countries

Europe, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026