Monthly Dosing of Atacicept in IgAN (NCT07020923) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Monthly Dosing of Atacicept in IgAN
United States90 participantsStarted 2025-05-29
Plain-language summary
This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments
* Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments
* Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
* Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinine ratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample
* eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
* On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1
Exclusion Criteria:
* IgAN secondary to another condition (eg, liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (ie, Henoch-Schonlein purpura), systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis
* Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
* Evidence of nephrotic syndrome within 6 months of screening (serum albumin \<3.0 g/dL in association with UPCR \>3.5 mg/mg)
* Renal or other organ transplantation prior to or expected during the study, with…
What they're measuring
1
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN