a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").
a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period"). The study will consist of 14 clinic visits over a period of 24 weeks. There will be a screening period of up to 14 days; Approximately 230 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either KRX-0502 or matching placebo, at baseline
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
234
1 g ferric citrate containing approximately 210 mg of ferric iron
Matching placebo
Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period
Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.
Time frame: Week 16
Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline
The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.
Time frame: Baseline and week 16
Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline
The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.
Time frame: Baseline and week 16
Mean Change in Ferritin at the End of 16 Weeks Minus Baseline
The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.
Time frame: Baseline and week 16
Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)
Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period
Time frame: Week 16
Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline
The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.
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Time frame: Baseline and week 16