A Phase 1 interventional study of Atacicept in Lupus Nephritis, sponsored by EMD Serono. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-22.
Sponsored by EMD Serono (part of Merck KGaA, Darmstadt, Germany) · Phase 1, Interventional, and Treatment
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.
338 studies on the registry are indexed under Lupus Nephritis; 131 are open to participants now.
This study's enrollment of 1 is below the median of 48 across 237 interventional studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →EMD Serono is the lead sponsor of 91 studies on the registry; none are open to participants now.
First submitted after EMD Serono became part of Merck KGaA, Darmstadt, Germany.
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Exclusion Criteria:
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
The nature (preferred terms) and incidence of AEs
Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen.
Time frame: 12 weeks
Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease
Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented.
Time frame: 12 weeks
The frequency and severity of laboratory abnormalities
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.
Time frame: 12 weeks
The nature (preferred terms) and incidence of AEs
Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen.
Time frame: 36 weeks
Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease
Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented.
Time frame: 36 weeks
The frequency and severity of laboratory abnormalities
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.
Time frame: 36 weeks
This study is terminated, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: TACI receptor-IgG Fc fragment fusion protein