Effect of Paricalcitol vs Calcitriol on Hemoglobin Levels in Chronic Kidney Disease Patients: A Randomized Trial

• Published in: PloS one Vol. 10; no. 3; p. e0118174
• Main Authors: Riccio, Eleonora, Sabbatini, Massimo, Bruzzese, Dario, Capuano, Ivana, Migliaccio, Silvia, Andreucci, Michele, Pisani, Antonio
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 17.03.2015; Public Library of Science (PLoS)
• Subjects: Anemia; Bone marrow; C-reactive protein; C-Reactive Protein - metabolism; Calcitriol; Calcitriol - pharmacology; Calcitriol - therapeutic use; Calcium; Calcium (blood); Calcium phosphates; Chronic kidney failure; Comparative analysis; Ergocalciferols - pharmacology; Ergocalciferols - therapeutic use; Female; Follow-Up Studies; Hemoglobin; Hemoglobins; Hemoglobins - metabolism; Humans; Hypertension; Inflammation; Iron; Kidney diseases; Kidneys; Male; Markers; Middle Aged; Nephrology; Nutrient deficiency; Parathyroid hormone; Parathyroid hormones; Patients; Peritoneal dialysis; Phosphates; Phosphorus; Plasma levels; Proteins; Proteinuria; Public health; Randomization; Renal Insufficiency, Chronic - drug therapy; Renal Insufficiency, Chronic - metabolism; Rodents; Studies; Treatment Outcome; Vitamin D; Vitamin deficiency; Italy
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0118174

Recent studies suggest that vitamin D deficiency represents an additional cofactor of renal anemia, with several mechanisms accounting for this relationship. In line with it, the administration of vitamin D or its analogues has been associated with an improvement of anemia. There are no data, however, about a direct effect of paricalcitol on hemoglobin (Hb) levels. Therefore, we conducted a study to determine whether paricalcitol, compared to calcitriol, improves anemia in patients with chronic kidney disease (CKD). In this randomized trial 60 CKD patients stage 3b-5 and anemia (Hb levels: 10-12.5 g/dL) were assigned (1:1) to receive low doses of calcitriol (Group Calcitriol) or paricalcitol (Group Paricalcitol) for 6 months. All the patients had normal values of plasma calcium, phosphorus and PTH, a stable iron balance, and normal values of C-Reactive Protein. The primary endpoint was to evaluate the effects of the two treatments on Hb levels; the modifications in 24hr-proteinuria (UProt) were also evaluated. A significant Group x Time interaction effect was observed in the longitudinal analysis of Hb levels (F(1,172)=31.4, p<0.001). Subjects in Paricalcitol experienced a significant monthly increase of Hb levels equal to +0.16 g/dL [95% C.I. 0.10 to +0.22, p<0.001) while in Group Calcitriol, Hb decrease throughout the follow-up with an average monthly rate of -0.10 g/dL (95% C.I.: -0.17 to -0.04, p<0.001). In Group Paricalcitol, UProt was significantly reduced after 6 months [0.35 (0.1-1.2) vs 0.59 (0.2-1.6), p<0.01], whereas no significant difference emerged in Group Calcitriol. Plasma levels of calcium, phosphate, PTH and of inflammation markers remained in the normal range in both groups throughout the study. Short-term exposure to paricalcitol results in an independent increase in Hb levels, which occurred with no modification of iron balance, inflammatory markers, and PTH plasma concentrations, and was associated with a decrease in UProt. ClinicalTrials.gov NCT01768351.