期刊
CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
卷 5, 期 2, 页码 299-306出版社
AMER SOC NEPHROLOGY
DOI: 10.2215/CJN.07131009
关键词
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资金
- National Kidney Foundation of Indiana
- Indiana Clinical and Translational Sciences Institute, Indiana Clinical Research Center, National Institutes of Health [UL RR025761]
- National Institutes of Health [DK002775]
Background and objectives: The optimal treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) is unknown. Design, setting, participants, & measurements: We conducted a randomized, blinded, 3-month trial in vitamin D-deficient CKD stage 3 and 4 patients with parathyroid hormone (PTH) values above the Kidney Disease Outcomes Quality Initiative target, comparing cholecalciferol (4000 IU/d x 1 month, then 2000 IU/d; n = 22) to doxercalciferol (1 mu g/d; n = 25). Results: There was no difference in baseline demographics or lab tests, except a slightly higher estimated GFR (eGFR) in the doxercalciferol group. There was a significant increase in vitamin D level in the cholecalciferol group (14 +/- 6 to 37 +/- 10 ng/ml; P < 0.001) but no change in the doxercalciferol group. The PTH decreased by 27% +/- 34% in the doxercalciferol group (P = 0.002) and decreased by 10% +/- 31% in the cholecalciferol group (P = 0.16), but the difference between treatments was NS (P = 0.11). Similar results were found when absolute PTH change from baseline to end point was analyzed in a repeated-measures ANOVA model. The serum calcium and urine calcium excretions were not different. Additional non-mineral-related end points, albuminuria, and BP were evaluated, and although trends were present, this did not reach significance. Conclusions: This prospective, randomized trial demonstrated a within-group reduction in PTH in the doxercalciferol-treated patients but no significant difference between the doxercalciferol and cholecalciferol patients. Larger, long-term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related end points and safety. Clin J Am Soc Nephrol 5: 299-306, 2010. doi: 10.2215/CJN.07131009
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