Efficacy and Safety of Atacicept in IgA Nephropathy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: IgA Nephropathy

In brief

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.

Key facts

Study ID

NCT02808429

Run by

EMD Serono Research & Development Institute, Inc.

People needed

16

Starts

2017-01-31

Expected to finish

2020-02-07

Last updated by the study team

2021-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AKDHC Medical Research Services, LLC. — Glendale, Arizona, United States
• California Institute of Renal Research - Chula Vista Location — Chula Vista, California, United States
• Colorado Kidney Care PC - Dr. Marder — Denver, Colorado, United States
• Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Southeastern Clinical Research Institute, LLC — Augusta, Georgia, United States
• GA Nephrology Associates — Lawrenceville, Georgia, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Columbia University Medical Center — New York, New York, United States
• Brookview Hills Research Associates, LLC — Winston-Salem, North Carolina, United States
• Ohio State University Clinical Trials Management Office - Ohio State CTMO Parent — Columbus, Ohio, United States
• Northeast Clinical Research Center, LLC — Bethlehem, Pennsylvania, United States
• Southeast Renal Research Institute — Chattanooga, Tennessee, United States
• Nephrotex Research Group — Dallas, Texas, United States
• Providence Sacred Heart Medical Center & Children's Hospital — Spokane, Washington, United States
• Juntendo University Hospital - Dept of Nephrology/Hypertension — Bunkyō City, Japan
• University Hospitals of Leicester NHS Trust - ULTIMATE PARENT — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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