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Efficacy and Safety of Atacicept in IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT02808429
Recruitment Status : Terminated (Study was terminated early as per sponsor decision due to unexpectedly slow enrollment.)
First Posted : June 21, 2016
Results First Posted : February 25, 2021
Last Update Posted : February 25, 2021
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: Placebo Drug: Atacicept 25 mg Drug: Atacicept 75 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
Actual Study Start Date : January 31, 2017
Actual Primary Completion Date : February 7, 2020
Actual Study Completion Date : February 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Placebo Drug: Placebo
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
Experimental: Atacicept 25 mg Drug: 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.
Experimental: Atacicept 75 mg Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: Baseline up to 96 weeks ]
    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).


Secondary Outcome Measures :
  1. Serum Atacicept Concentrations [ Time Frame: 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 ]
    Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.

  2. Change From Baseline Levels in Serum Immunoglobulin A (IgA) [ Time Frame: 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 ]
    The change in serum levels of IgA from baseline was reported.

  3. Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) [ Time Frame: 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 ]
    The change in serum levels of IgG from baseline was reported.

  4. Change From Baseline Levels in Serum Immunoglobulin M (IgM) [ Time Frame: 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 ]
    The change in serum levels of IgM from baseline was reported.

  5. Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels [ Time Frame: Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24 ]
    The change in serum Gd-IgA1 from baseline was reported.

  6. Change From Baseline in Serum Complement C3 and C4 Levels [ Time Frame: Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24 ]
    The change in serum component C3 and C4 from baseline were reported.

  7. Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis [ Time Frame: Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24 ]
    Change from baseline in immune cell subsets included total T cells, helper T cells, cytotoxic T cells, total B cells (assay with [AW] CD45 or assay without [AWO] CD45), mature naïve B cells, memory B cells, plasma cells, plasma blasts, and natural killer (NK) cells and were reported. Analysis was performed by flow cytometry analysis.

  8. Change From Baseline in Urinary IgG, IgA, and IgM Levels [ Time Frame: Baseline (Day1), Weeks 24, 48 and Early Termination (up to earlier than Week 72) ]
    Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis.

  9. Percentage of Participants With Positive Anti-Drug Antibody (ADA) [ Time Frame: Baseline up to safety follow-up (96 weeks) ]
    Percentage of participants with positive ADA were reported.

  10. Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments [ Time Frame: Baseline up to safety follow-up (96 weeks) ]
    Laboratory investigation included hematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator.

  11. Percentage of Participants With Clinical Significant Abnormalities in Vital Signs [ Time Frame: Baseline up to safety follow-up (96 weeks) ]
    Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, weight and height. The systolic and diastolic blood pressure and pulse rate was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was to be decided by the investigator.

  12. Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs) [ Time Frame: Baseline up to safety follow-up (96 weeks) ]
    12-lead ECG were recorded after the participants have rested for at least 15 minutes in supine position. Clinically significance was decided by the investigator. The number of participants with clinically significant abnormalities in 12-lead ECG were reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808429


Locations
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Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
  Study Documents (Full-Text)

Documents provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Study Protocol  [PDF] November 27, 2018
Statistical Analysis Plan  [PDF] February 15, 2019

More Information
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Additional Information:

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT02808429    
Other Study ID Numbers: MS700461-0035
2016-002262-31 ( EudraCT Number )
First Posted: June 21, 2016    Key Record Dates
Results First Posted: February 25, 2021
Last Update Posted: February 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Atacicept
IgA Nephropathy
Berger´s disease
Glomerulonephritis
Proteinuria
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
 Nephritis
Autoimmune Diseases
Immune System Diseases