Study Stopped
Study was terminated early as per sponsor decision due to unexpectedly slow enrollment.
Efficacy and Safety of Atacicept in IgA Nephropathy
A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
2 other identifiers
interventional
16
3 countries
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2017
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedStudy Start
First participant enrolled
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2020
CompletedResults Posted
Study results publicly available
February 25, 2021
CompletedFebruary 25, 2021
January 1, 2021
3 years
June 16, 2016
February 4, 2021
February 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
Adverse Event (AE): any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: AEs that developed or worsened/became serious during on-treatment period (time from the first dose of study drug up to the end of study \[Week 96\]). TEAEs included serious AEs and non- serous AEs. AESIs included infections, cardiac failure, cardiomyopathy/ ischemic heart disease, hypersensitivity reaction (including anaphylactic/anaphylactoid shock conditions, asthma/bronchospasm, and angioedema), injection site reactions (ISRs) and demyelinating disorders. Investigator or his /her designee assessed ISRs as local reactions (redness, bruising, swelling, induration and itching).
Baseline up to 96 weeks
Secondary Outcomes (12)
Serum Atacicept Concentrations
Week 0 Day 1 (pre-dose), Weeks 1, 2, 4, 8, 12, 16, 24, 40, 48, 72, Early Termination (up to Week 72) and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and at PT FU Weeks 4, 12 and 24
Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels
Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24
- +7 more secondary outcomes
Study Arms (3)
Placebo
EXPERIMENTALAtacicept 25 mg
EXPERIMENTALAtacicept 75 mg
EXPERIMENTALInterventions
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
AKDHC Medical Research Services, LLC.
Glendale, Arizona, 85308, United States
California Institute of Renal Research - Chula Vista Location
Chula Vista, California, 91910, United States
Colorado Kidney Care PC - Dr. Marder
Denver, Colorado, 80218, United States
Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, 30909, United States
GA Nephrology Associates
Lawrenceville, Georgia, 30046, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Columbia University Medical Center
New York, New York, 10032, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103, United States
Ohio State University Clinical Trials Management Office - Ohio State CTMO Parent
Columbus, Ohio, 43210, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404, United States
Nephrotex Research Group
Dallas, Texas, 75231, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204, United States
Juntendo University Hospital - Dept of Nephrology/Hypertension
Bunkyō City, 113-8431, Japan
University Hospitals of Leicester NHS Trust - ULTIMATE PARENT
Leicester, LE5 4PW, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated due to poor enrollment and Part B was not conducted as per Sponsor decision. This decision was not related to any safety or efficacy findings regarding Atacicept.
Results Point of Contact
- Title
- Communication Center
- Organization
- Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2016
First Posted
June 21, 2016
Study Start
January 31, 2017
Primary Completion
February 7, 2020
Study Completion
February 7, 2020
Last Updated
February 25, 2021
Results First Posted
February 25, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website.