Penny Study - Adma Analysis

This database comes from the PENNY study, a double-blind, randomized, parallel group trial (ClinicalTrials.gov identifier, NCT01680198) enrolling 88 patients with CKD stage 3 to 4, age ranging between 18 and 80 years, parathormone > 65 pg/ml, serum total Ca between 2.2 and 2.5 mmol/L and phosphate levels between 2.9 mg/dL and 4,5 mg/dL, not in treatment with vitamin D compounds or anti-epileptic drugs, without neoplasia or symptomatic cardiovascular disease or liver disease. Patients who met the inclusion criteria were randomized (1:1) to receive 2 µg paricalcitol once daily or matching placebo for 12 weeks after a 2-week run-in. The dose of paricalcitol was adjusted on the basis of serum parathormone and Ca and the maximum dose allowed was 2 µg daily. No vitamin D compounds were allowed during the trial.本数据库来源于PENNY研究，这是一项双盲随机平行分组试验（ClinicalTrials.gov注册号：NCT01680198）。该试验共纳入88例3至4期慢性肾脏病（CKD）患者，受试者年龄介于18至80岁，甲状旁腺激素＞65pg/ml，血清总钙水平为2.2~2.5mmol/L，磷酸盐水平为2.9~4.5mg/dL；所有受试者均未接受维生素D类药物或抗癫痫药物治疗，且无肿瘤、症状性心血管疾病或肝脏疾病。符合纳入标准的患者按1:1比例随机分组，在2周导入期后，每日接受1次2μg帕立骨化醇或匹配安慰剂，干预时长为12周。帕立骨化醇的剂量可根据血清甲状旁腺激素与钙水平进行调整，每日最大允许剂量为2μg。试验期间严禁使用任何维生素D类药物。