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Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil

This study has been terminated.
(Please see Purpose Statement below)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369628
First Posted: June 9, 2011
Last Update Posted: October 22, 2013
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.
Information provided by (Responsible Party):
EMD Serono
  Purpose
The sponsor electively terminated the study because the risk mitigation measures, deemed necessary after an unforeseen safety event, could not be effectively implemented within this protocol while maintaining study timelines within a reasonable time frame.

Condition Intervention Phase
Lupus Nephritis Drug: Atacicept Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Multicenter, Open Label, Dose-Escalating, Repeat-Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Atacicept When Administered to Subjects With Lupus Nephritis on a Stable Regimen of Mycophenolate Mofetil (MMF) With or Without Corticosteroids

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • The nature (preferred terms) and incidence of AEs [ Time Frame: 12 weeks ]
    Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen.

  • Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease [ Time Frame: 12 weeks ]
    Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented.

  • The frequency and severity of laboratory abnormalities [ Time Frame: 12 weeks ]
    The incidence of subjects given each atacicept regimen who have shifts from Baseline in serum creatinine, serum albumin, urinary protein, or Hematology test (counts of white blood cells, neutrophils, lymphocytes, platelets) of at least 2 grades will be presented. Grading will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 toxicity grading, using the worst grade post-baseline during the 12-week treatment period.


Secondary Outcome Measures:
  • The nature (preferred terms) and incidence of AEs [ Time Frame: 36 weeks ]
    Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen.

  • Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease [ Time Frame: 36 weeks ]
    Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented.

  • The frequency and severity of laboratory abnormalities [ Time Frame: 36 weeks ]
    The incidence of subjects given each atacicept regimen who have shifts from Baseline in serum creatinine, serum albumin, urinary protein, or Hematology test (counts of white blood cells, neutrophils, lymphocytes, platelets) of at least 2 grades will be presented. Grading will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 toxicity grading, using the worst grade post-baseline during the 12-week treatment period.


Enrollment: 1
Study Start Date: June 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

1 arm with the 3 following dose regimens:

  1. Regimen 1: Atacicept 25 mg weekly for 12 weeks
  2. Regimen 2: Atacicept 75 mg weekly for 12 weeks
  3. Regimen 3: Atacicept 150 mg weekly for 12 weeks
Drug: Atacicept
  1. Regimen 1: Atacicept 25 mg weekly for 12 weeks
  2. Regimen 2: Atacicept 75 mg weekly for 12 weeks
  3. Regimen 3: Atacicept 150 mg weekly for 12 weeks

Detailed Description:
This study will evaluate atacicept's effects in subjects who have lupus nephritis, at least 2 g/day of protein in the urine, and are already taking mycophenolate mofetil. The evaluations will include the concentrations of atacicept in the blood, the effects of atacicept on immunoglobulins (antibodies), and any side effects. The first subjects will be given a low dose. Following periodic reviews of the trial data, subsequent subjects are planned to receive one of 2 progressively higher doses of atacicept.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or female subjects, ≥ 18 years of age, who provide written informed consent
  • Subjects must have a diagnosis of SLE satisfying ≥ 4 of 11 ACR criteria, and must have had a renal biopsy during screening or within the previous 18 months demonstrating class III (A or A/C), IV (A or A/C), V, or concomitant III/V or IV/V LN as defined by the International Society of Nephrology/Renal Pathology Society (ISN/RPS).
  • Subjects must have a urine protein: creatinine ratio ≥ 2 mg/mg (≥ 226.2 mg/mmol), and either a positive test for antinuclear antibody (ANA) (HEp-2 ANA ≥ 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) (≥ 30 IU/mL) at screening.
  • Subjects must have started induction therapy for LN at least 5 months prior to Trial Day 1, be considered to have received continuous treatment for LN during the 5 months prior to Trial Day 1, and have received a stable dose of MMF ≥ 1 g/day, with or without corticosteroids, for at least 8 weeks prior to Trial Day 1.

Exclusion Criteria:

  • Recent changes in immunosuppressant, ACD inhibitors for ARBs
  • Use of azathioprine, cyclosporine, tacrolimus, or cyclophosphamide or other biologics within 8 weeks prior to Trial Day 1.
  • Serum IgG < 6 g/L
  • Estimated Glomerular Filtration Rate (GFR) ≤ 30 mL/min per 1.73 m2
  • History of Demyelinating Disease
  • Significant Hematuria and/or Proteinuria due to a reason(s) other than LN. Evaluation should be done according to the local standard of care
  • Breast feed or pregnancy
  • Legal Incapacity or limited legal capacity
  Contacts and Locations
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): NCT01369628


Locations
United States, Massachusetts
EMD Serono Inc., One Technology Place
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
  More Information

Additional Information:
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01369628     History of Changes
Other Study ID Numbers: EMR 700461_014
First Submitted: June 7, 2011
First Posted: June 9, 2011
Last Update Posted: October 22, 2013
Last Verified: October 2013

Keywords provided by EMD Serono:
Open label
Dose Escalating
Phase Ib

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action