Paricalcitol Effect on Anemia in CKD
Paricalcitol Effect on Anemia in CKD
Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism
 in chronic kidney disease (CKD), and a large body of experimental data in animals confirms
 the effects of Vitamin D that extend beyond mineral metabolism. Several studies show that the
 benefits are greater with the newer vitamin D analog paricalcitol when compared with
 calcitriol. A large gap exists in our knowledge between epidemiological studies in human that
 demonstrate improved outcomes with vitamin D use and observations in preclinical studies
 demonstrating the pleiotropic effects of Vitamin D. To explore the provenance of
 epidemiological outcomes in CKD, we conducted a pilot randomized trial to determine whether
 the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker
 associated with worse outcomes in chronic kidney disease, and whether this effect not only
 reflects the hyperparathyroidism correction, but is also dependent on the direct effects of
 paricalcitol on erythroid progenitor cells.
To better understand the direct effects of paricalcitol on anemia in patients with chronic
 kidney disease (stage 3-5), we conducted a pilot trial in 60 patients who were randomly
 allocated equally to 2 groups to receive or not paricalcitol orally for 6 months.
Inclusion criteria:

 -  age > 18

 -  written informed consent

 -  CKD stage 3-5 (eGFR <60 ml/min/1,73 m2)

 -  PTH 30-300 pg/ml

 -  Hb <10 g/dl >3 consecutive months

 -  Ferritin > 100 ng/ml

 -  transferrin saturation (TSAT) 20-40%

 -  mean corpuscular volume (MCV) 85-95%

 -  for patients treated with Ace-inhibitors or angiotensin receptor blockers, dose stable
 >3 months

 -  for patients treated with erythropoiesis-stimulating agents (ESA), dose stable >3
 months

 Exclusion criteria:

 -  anemia due to non renal cause

 -  presence of malignancies, inflammatory or infectious disease >3 months

 -  pregnancy

 -  bleeding >6 months

 -  C-reactive protein (CRP) >1 mg/dl

 -  poorly controlled hypertension (PAS > 170 mmHG and PAD >100 mmHg)

 -  severe malnutrition

 -  hypercalcemia (>10,5 mg/dl)

 -  hyperphosphatemia (>5,5 mg/dl)

 -  surgical interventions >3 months

 -  acute myocardial infarction, unstable angina, stroke or transitory ischemic attack,
 deep venous or pulmonary thromboembolism, congestive heart failure >3 months