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Efficacy and Safety of Atacicept in IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT02808429
Recruitment Status : Active, not recruiting
First Posted : June 21, 2016
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
This study will evaluate the safety, tolerability, dose response and efficacy of atacicept in patients with IgA nephropathy and persistent proteinuria. The study hypothesis is that treatment with atacicept will reduce proteinuria compared to placebo.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: Atacicept 25 mg Drug: Atacicept 75 mg Drug: Placebo Drug: Atacicept 150 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : July 8, 2020
Estimated Study Completion Date : July 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Part A: Atacicept 25 mg Drug: Atacicept 25 mg
Subject will receive Atacicept 25 milligram (mg) once weekly as a subcutaneous (SC) injection for 72 weeks.

Experimental: Part A: Atacicept 75 mg Drug: Atacicept 75 mg
Subject will receive Atacicept 75 mg once weekly as an SC injection for 72 weeks.

Placebo Comparator: Part A: Placebo Drug: Placebo
Subject will receive matching Placebo to atacicept once weekly as an SC injection for 72 weeks.

Experimental: Part B: Atacicept 25 mg Drug: Atacicept 25 mg
Subject will receive Atacicept 25 mg once weekly as an SC injection for 156 weeks.

Experimental: Part B: Atacicept 75 mg Drug: Atacicept 75 mg
Subject will receive Atacicept 75 mg once weekly as an SC injection for 156 weeks

Experimental: Part B: Atacicept 150 mg Drug: Atacicept 150 mg
Subject will receive Atacicept 150 mg once weekly as an SC injection for 156 weeks.

Placebo Comparator: Part B: Placebo Drug: Placebo
Subject will receive matching Placebo to atacicept once weekly as an SC injection for 156 weeks.




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 ]


Information from the National Library of Medicine

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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

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


  Show 19 Study Locations
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

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT02808429     History of Changes
Other Study ID Numbers: MS700461-0035
2016-002262-31 ( EudraCT Number )
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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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