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.