Paricalcitol Effect on Anemia in CKD
Although current activated vitamin D therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (CKD), 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 humans 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 patients with CKD, we conducted a pilot placebo-controlled trial to determine whether the use of paricalcitol 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.
Chronic Kidney Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease|
- Modification in hemoglobin levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Control
Patients receiving treatment for secondary hyperparathyroidism with calcitriol. The calcitriol dosage schedule provided for an initial dose calculated according to body weight (0.01 mg/kg thrice weekly), and titration was performed on the basis of the serum levels of intact PTH (iPTH) (target 150-300 pg/mL), Ca, P and Ca x P product as suggested by the US National Kidney Foundation Dialysis outcomes Quality Initiative (NKF-DOQI) and Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. At the same way, the patients not treated started therapy if their values needed, as suggested by the NKF-DOQI and KDIGO guidelines.
Rocaltrol cp 0,25 mcg, 0,5 mcg or 1 mcg/die or alternate days per os
Other Name: Rocaltrol
Patients treated by Paricalcitol for hyperparathyroidism. The paricalcitol initial dose was 1 mcg/die, and titration was performed on the basis of the serum levels of iPTH, Ca, P and Ca x P product as suggested by the NKF-DOQI and KDIGO guidelines.
Zemplar cp 1 mcg or 2 mcg/die per os
Other Name: Zemplar
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768351
|Federico II University|
|Naples, Italy, 80129|
|Principal Investigator:||Eleonora Riccio, MD|