Efficacy and Safety of Atacicept in IgA Nephropathy

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 2

Conditions: IgA Nephropathy

Treatments: Drug: Placebo; Drug: Atacicept 25 mg; Drug: Atacicept 75 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02808429

2016-002262-31 (EudraCT Number)

MS700461-0035

Details and patient eligibility

About

This main purpose of this study was to evaluate the safety, tolerability, dose response and efficacy of Atacicept in participants with IgA nephropathy and persistent proteinuria. The study hypothesis was that treatment with Atacicept would reduce proteinuria compared to placebo.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to (>=)18 years of age
• Biopsy-proven Immunoglobulin (IgA) nephropathy
• Urine Protein to Creatinine Ratio (UPCR) >= 0.75 and <= 6 milligram per milligram (mg/mg) during screening
• Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening

Exclusion criteria

• Concomitant significant renal disease other than IgA nephropathy
• IgA nephropathy with significant glomerulosclerosis or cortical scarring
• Diagnosis of Henoch-Schonlein purpura
• Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement criteria
• Serum IgG below 6 grams per liter (g/L)
• Use of cyclophosphamide ever or use of other immunosuppressants or systemic corticosteroids within 4 months
• Active infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks
• History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB infection
• History of or positive HIV and/or positive for hepatitis B or Hepatitis C at screening
• History of malignancy
• Nursing or pregnancy
• Any condition, including any uncontrolled disease state other than IgA nephropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

16 participants in 3 patient groups

Placebo

Experimental group

Treatment:

Drug: Placebo

Atacicept 25 mg

Experimental group

Treatment:

Drug: Atacicept 25 mg

Atacicept 75 mg

Experimental group

Treatment:

Drug: Atacicept 75 mg