Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil (NCT01369628) | Clinical Trial Compass
TerminatedPhase 1
Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil
Stopped: Please see Purpose Statement below
United States1 participantsStarted 2011-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
What they're measuring
1
The nature (preferred terms) and incidence of AEs
Timeframe: 12 weeks
2
Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease
Timeframe: 12 weeks
3
The frequency and severity of laboratory abnormalities