This is a Phase 1b, randomized, double-blinded, placebo-controlled study of CTX001 in participants with anemia and chronic kidney disease who are not on dialysis. The primary objective is to assess the preliminary safety and tolerability of CTX001 administered with iron in this patient population. Secondary objectives include assessment of concentrations of CTX001 in the blood at different dose levels, and the impact of administration of CTX001 with iron on blood iron levels and other hematologic parameters.
Up to 2 different doses of CTX001 are planned to be tested in cohorts of 12 participants each, for a total planned enrollment of up to 24 participants. An additional group of up to 12 participants may be enrolled to evaluate an additional dose level. Eligible participants will be randomly assigned in a 3:1 ratio to receive CTX001 or placebo, together with an oral iron supplement, for 29 days.
