KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD (NCT02268994) | Clinical Trial Compass
CompletedPhase 3
KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
United States234 participantsStarted 2014-10
Plain-language summary
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").
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening
✓. Age ≥18 years
✓. CKD with Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (with a limit of up to 20% of the target randomization of 230 subjects with eGFR \<15 mL/min)
✓. Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements (in the opinion of the investigator)
✓. Hgb ≥ 9.0 g/dL and ≤11.5 g/dL at Screening
✓. Serum ferritin ≤200 ng/mL and Transferrin Saturation (TSAT) ≤25% at Screening
✓. Serum Intact Parathyroid Hormone (iPTH) ≤600 pg/mL at Screening
✓. Must consume a minimum of 2 meals per day
Exclusion criteria
✕. Serum phosphate \<3.5 mg/dL at Screening
✕. Liver enzymes (ALT/AST) \>X3 times upper limit of normal at Screening
✕. Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening
✕. Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening
What they're measuring
1
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