Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2017-01-31
2020-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
Atacicept 25 mg
Atacicept 25 mg
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
Atacicept 75 mg
Atacicept 75 mg
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
Interventions
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Placebo
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
Atacicept 25 mg
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
Atacicept 75 mg
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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US Medical Information website, Medical Resources
Trial Awareness and Transparency website
Other Identifiers
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2016-002262-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS700461-0035
Identifier Type: -
Identifier Source: org_study_id
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