primary Outcome Measures:
Safety [ Time Frame: From first study drug dose for up to 26 weeks ] [ Designated as safety issue: No ]
Incidence and severity of adverse events (AE) will be assessed at every visit. AEs and serious adverse events (SAEs) will be assessed from the first dose of study drug through 33 days after the last dose
They have already increased the time from 4 to 8 weeks probably looks okay.
Time to normalization of serum levels of C3 or C3 breakdown products and duration of normalization and assays of alternative pathway activity. These blood tests will be assessed on each dosing day and upon Study Completion /Termination.
This could be a major advantage over other products here
Renal Function [ Time Frame: Regularly from study start up to 26 weeks ] [ Designated as safety issue: No ]
Stabilization and/or improvement in renal function (as measured by serum creatinine and proteinuria). These lab tests will be performed weekly during the Induction Period, monthly during the Maintenance Period and upon Study Completion /Termination.
These function lead to other indications in the future, think diabetes
Renal biopsy [ Time Frame: Occurs up to 3 times from study start up to 26 weeks ] [ Designated as safety issue: No ]
Renal biopsy could mean many things will be curious to see this part.
There are other outcomes but this is the just of the trial. Remember phase 1 studies search for safety and dosing to move to phase 2 studies. I say we see a phase 2/3 study with early approval for this product if everything looks good early on. Probably same time approval late 2015 to mid 2016