Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil

This study has been terminated.
(Please see Purpose Statement below)
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01369628
First received: June 7, 2011
Last updated: October 21, 2013
Last verified: October 2013

June 7, 2011
October 21, 2013
June 2011
November 2011   (final data collection date for primary outcome measure)
  • The nature (preferred terms) and incidence of AEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
Same as current
Complete list of historical versions of study NCT01369628 on ClinicalTrials.gov Archive Site
  • The nature (preferred terms) and incidence of AEs [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lupus Nephritis
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
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
Intervention: Drug: Atacicept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
Not Provided
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01369628
EMR 700461_014
Yes
EMD Serono
EMD Serono
Not Provided
Not Provided
EMD Serono
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP