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Efficacy and Safety of Atacicept in IgA Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02808429
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : July 16, 2020
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 for 72 weeks.
Experimental: Atacicept 25 mg Drug: Atacicept 25 mg
Partcipants received 25 milligrams (mg) of Atacicept once weekly as SC injection for 72 weeks.
Experimental: Atacicept 75 mg Drug: Atacicept 75 mg
Partcipants received 75 mg of Atacicept once weekly as SC injection for 72 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Part A: Proportion of subjects with Adverse events (AE), AEs of special interest (AESIs), serious AEs, AEs leading to discontinuation, and AEs leading to death [ Time Frame: Up to 48 weeks ]
  2. Part B: Percent change from baseline in proteinuria at Week 48 [ Time Frame: Baseline and Week 48 ]

Secondary Outcome Measures :
  1. Part A: Serum atacicept concentrations [ Time Frame: Baseline, up to 96 weeks ]
  2. Part A: Change from baseline levels in serum immunoglobulin (Ig) classes (IgG, IgA, and IgM) [ Time Frame: Baseline, up to 96 weeks ]
  3. Part A: Change from baseline in serum Galactose Deficient-IgA1 (Gd-IgA1) levels [ Time Frame: Baseline, up to 96 weeks ]
  4. Part A: Change from baseline in serum complement C3 and C4 levels [ Time Frame: Baseline, up to 96 weeks ]
  5. Part A: Change from baseline in immune cell subsets by flow cytometry analysis [ Time Frame: Baseline, up to 96 weeks ]
  6. Part A: Change in urine immuno-electrophoresis pattern [ Time Frame: Baseline, up to 96 weeks ]
  7. Part A: Proportion of subjects positive for Anti-drug antibody assessment [ Time Frame: Up to 96 weeks ]
  8. Part A: Proportion of subjects with Clinical significant abnormalities in laboratory assessments, vital signs and electrocardiograms (ECGs) [ Time Frame: Up to 96 weeks ]
  9. Part B: Proportion of subjects achieving reduction in proteinuria from Baseline and with stable renal function [ Time Frame: Baseline, Week 48 ]
  10. Part B: Change from Baseline in Renal Function [ Time Frame: Baseline, Week 156 ]
  11. Part B: Serum atacicept concentrations [ Time Frame: Baseline, up to 180 weeks ]
  12. Part B: Change from baseline levels in serum immunoglobulin (Ig) classes (IgG, IgA, and IgM) [ Time Frame: Baseline, up to 180 weeks ]
  13. Part B: Change from baseline in serum Galactose Deficient-IgA1 (Gd-IgA1) levels [ Time Frame: Baseline, up to 180 weeks ]
  14. Part B: Change from baseline in serum complement C3 and C4 levels [ Time Frame: Baseline, up to 180 weeks ]
  15. Part B: Change from baseline in immune cell subsets by flow cytometry analysis [ Time Frame: Baseline, up to 180 weeks ]
  16. Part B: Change in urine immuno-electrophoresis pattern [ Time Frame: Baseline, up to 180 weeks ]
  17. Part B: Proportion of subjects positive for Anti-drug antibody assessment [ Time Frame: Up to 180 weeks ]
  18. Part B: Proportion of subjects with AEs, AESIs, AEs leading to discontinuation, SAEs, AEs leading to death [ Time Frame: Up to 180 weeks ]
  19. Part B: Proportion of subjects with Clinical significant Abnormalities in laboratory assessments, vital signs and electrocardiograms (ECGs) [ Time Frame: Up to 180 weeks ]

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
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
Last Update Posted: July 16, 2020
Last Verified: July 2020
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