ferric-oxide--saccharated and Calcinosis

In patients on maintenance dialysis, cardiovascular mortality risk is remarkably high, which can be partly explained by severe coronary artery calcification (CAC). Hyperphosphatemia has been reported to be associated with the severity of CAC. However, the optimal phosphate range in patients on dialysis remains unknown. This study was planned to compare the effects on CAC progression of two types of noncalcium-based phosphate binders and of two different phosphate target ranges.. We conducted a randomized, open-label, multicenter, interventional trial with a two by two factorial design. A total of 160 adults on dialysis were enrolled and randomized to the sucroferric oxyhydroxide or lanthanum carbonate group, with the aim of reducing serum phosphate to two target levels (3.5-4.5 mg/dl in the strict group and 5.0-6.0 mg/dl in the standard group). The primary end point was percentage change in CAC scores during the 12-month treatment.. The full analysis set included 115 patients. We observed no significant difference in percentage change in CAC scores between the lanthanum carbonate group and the sucroferric oxyhydroxide group. On the other hand, percentage change in CAC scores in the strict group (median of 8.52; interquartile range, -1.0-23.9) was significantly lower than that in the standard group (median of 21.8; interquartile range, 10.0-36.1;. Further study with a larger sample size is needed, but strict phosphate control shows promise for delaying progression of CAC in patients undergoing maintenance hemodialysis.. Evaluate the New Phosphate Iron-Based Binder Sucroferric Oxyhydroxide in Dialysis Patients with the Goal of Advancing the Practice of EBM (EPISODE), jRCTs051180048.

Topics: Adult; Aged; Calcinosis; Coronary Artery Disease; Disease Progression; Drug Combinations; Female; Ferric Compounds; Humans; Hyperphosphatemia; Lanthanum; Male; Middle Aged; Phosphates; Renal Dialysis; Sequestering Agents; Sucrose; Young Adult

In dialysis patients, mortality risk due to cardiovascular diseases is remarkably high and prognosis is poor; coronary artery calcification is considered one of the major contributing factors. It is known that hyperphosphatemia is associated with coronary artery calcification. Therefore, controlling serum phosphate level and thereby mitigating vascular calcification could improve the poor prognosis of dialysis patients. However, the optimal phosphate level in dialysis patients remains unknown; hence, this study was planned to compare the effects of two types of non-calcium-based phosphate binders, and examine the effect of strict control of phosphate on coronary artery calcification.. EPISODE is a randomized, open-label, multi-center, interventional trial with a two-by-two factorial design (UMIN ID: UMIN000023648). This trial will enroll hemodialysis patients who have been on dialysis for at least 3 months with a pre-dialysis serum phosphate level of at least 5.0 mg/dL or at least 6.1 mg/dL, respectively, in those taking or not taking a phosphate binder, as measured during the observation period. Registered patients will be randomized to the sucroferric oxyhydroxide or lanthanum carbonate arm and will receive the assigned drug to reduce serum phosphate to two target levels (3.5-4.5 mg/dL in strict arm and 5.0-6.0 mg/dL in standard arm) for 12 months. The primary endpoint will be percent change in coronary artery calcification score, and the secondary endpoints will include change from baseline serum phosphate and calcium levels, change in renal anemia-related factors, etc. The desired sample size has been calculated to be 200 patients.

Topics: Calcinosis; Chelating Agents; Coronary Artery Disease; Drug Combinations; Ferric Compounds; Humans; Hyperphosphatemia; Iron; Phosphates; Randomized Controlled Trials as Topic; Renal Dialysis; Sucrose