Current research indicates that TTP488 may be a viable agent for the treatment of diabetic nephropathy. The purpose of this study is to determine the safety and efficacy of a six-month regimen of daily orally-administered TTP488 to patients with diabetic nephropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication
Placebo
Pfizer Investigational Site
Red Deer, Alberta, Canada
Pfizer Investigational Site
Penticton, British Columbia, Canada
Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR)
Time frame: from baseline to end of treatment (Month 6).
To evaluate treatment on estimated GFR and serum creatinine
Time frame: evaluated for change from baseline to months 3 & 6
To evaluate the effects of TTP488 on other relevant biomarkers
Time frame: evaluated at months 1, 3 & 6
To evaluate the safety of TTP488
Time frame: Ongoing
To evaluate the PK profile of oral TTP488.
Time frame: Ongoing
To evaluate the effect of treatment with TTP488 on UACR
Time frame: evaluated from baseline to month 3 visit
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Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Burlington, Ontario, Canada
Pfizer Investigational Site
Courtice, Ontario, Canada
Pfizer Investigational Site
Fort Erie, Ontario, Canada
Pfizer Investigational Site
Hamilton, Ontario, Canada
Pfizer Investigational Site
Kitchener, Ontario, Canada
Pfizer Investigational Site
Kitchener, Ontario, Canada
Pfizer Investigational Site
Millon, Ontario, Canada
...and 9 more locations