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IgA NephropathyPhase 2NCT02808429

Efficacy and Safety of Atacicept in IgA Nephropathy

A Phase 2 study testing Atacicept 25 mg and Atacicept 75 mg in people with IgA Nephropathy, run by EMD Serono Research & Development Institute, Inc. at 18 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Nephropathy
What is being tested?
Atacicept 25 mg and Atacicept 75 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
18 sitesin 3 countries
Study dates
31 Jan 2017to 7 Feb 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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 locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

United States16 sites

  • Southeastern Clinical Research Institute, LLC

    Augusta, Georgia, 30909

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Southeast Renal Research Institute

    Chattanooga, Tennessee, 37404

  • California Institute of Renal Research - Chula Vista Location

    Chula Vista, California, 91910

  • Ohio State University Clinical Trials Management Office - Ohio State CTMO Parent

    Columbus, Ohio, 43210

  • Nephrotex Research Group

    Dallas, Texas, 75231

  • Colorado Kidney Care PC - Dr. Marder

    Denver, Colorado, 80218

  • AKDHC Medical Research Services, LLC.

    Glendale, Arizona, 85308

  • GA Nephrology Associates

    Lawrenceville, Georgia, 30046

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Providence Sacred Heart Medical Center & Children's Hospital

    Spokane, Washington, 99204

  • Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan1 site

  • Juntendo University Hospital - Dept of Nephrology/Hypertension

    Bunkyō City, 113-8431

Other trials in Japan

United Kingdom1 site

  • University Hospitals of Leicester NHS Trust - ULTIMATE PARENT

    Leicester, LE5 4PW

Other trials in United Kingdom

About this study

Official title: A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy

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.

Conditions
IgA Nephropathy
Being tested
Placebo, Atacicept 25 mg, Atacicept 75 mg
Keywords
Atacicept, IgA Nephropathy, Berger´s disease, Glomerulonephritis, Proteinuria
Medical subject headings
Glomerulonephritis, IGA, Glomerulonephritis, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    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 mgDrug

    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 mgDrug

    Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.

Study groups in NCT02808429
Study groupRoleWhat they receive
PlaceboExperimentalNot described
Receives: Drug: Placebo
Atacicept 25 mgExperimentalNot described
Receives: Drug: Atacicept 25 mg
Atacicept 75 mgExperimentalNot described
Receives: Drug: Atacicept 75 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline up to 96 weeks

Secondary outcomes (12)

  1. Serum Atacicept Concentrations

    Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.

    Measured: 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

  2. Change From Baseline Levels in Serum Immunoglobulin A (IgA)

    The change in serum levels of IgA from baseline was reported.

    Measured: 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

  3. Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)

    The change in serum levels of IgG from baseline was reported.

    Measured: 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

  4. Change From Baseline Levels in Serum Immunoglobulin M (IgM)

    The change in serum levels of IgM from baseline was reported.

    Measured: 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

  5. Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels

    The change in serum Gd-IgA1 from baseline was reported.

    Measured: Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24

  6. Change From Baseline in Serum Complement C3 and C4 Levels

    The change in serum component C3 and C4 from baseline were reported.

    Measured: Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24

  7. Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis

    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.

    Measured: Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24

  8. Change From Baseline in Urinary IgG, IgA, and IgM Levels

    Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis.

    Measured: Baseline (Day1), Weeks 24, 48 and Early Termination (up to earlier than Week 72)

  9. Percentage of Participants With Positive Anti-Drug Antibody (ADA)

    Percentage of participants with positive ADA were reported.

    Measured: Baseline up to safety follow-up (96 weeks)

  10. Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments

    Laboratory investigation included hematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator.

    Measured: Baseline up to safety follow-up (96 weeks)

  11. Percentage of Participants With Clinical Significant Abnormalities in Vital Signs

    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.

    Measured: Baseline up to safety follow-up (96 weeks)

  12. Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)

    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.

    Measured: Baseline up to safety follow-up (96 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2016 (estimated)
  2. Study start31 Jan 2017
  3. Primary completion7 Feb 2020
  4. Study completion7 Feb 2020

Why it stopped: Study was terminated early as per sponsor decision due to unexpectedly slow enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02808429
Sponsor's protocol ID
MS700461-0035
Other IDs
2016-002262-31, 2016
Status last verified
Jan 2021
First submitted
16 Jun 2016
Last updated
25 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atacicept 25 mg and Atacicept 75 mg in people with IgA Nephropathy, run by EMD Serono Research & Development Institute, Inc. at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02808429.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.

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