Paricalcitol Effect on Anemia in CKD

Phase 4

Completed

• Conditions: Anemia; Chronic Kidney Disease
• Interventions: Drug: Calcitriol; Drug: Paricalcitol

• Registration Number: NCT01768351
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-03
• Study Completion: 2012-10
• Status Verified: 2012-11
• Study First Submitted: 2013-01-13
• Study First Submitted QC: 2013-01-13
• Study First Posted: 2013-01-15
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Calcitriol	Patients receiving treatment for secondary hyperparathyroidism with calcitriol. The calcitriol dosage schedule provided for an initial dose of 0.5 mch every other day 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.
Paricalcitol	Paricalcitol	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.

Primary Outcome Measures

Name	Time	Method
Modification in hemoglobin levels	6 months

Secondary Outcome Measures

Name	Time	Method
Modifications in urinary protein excretion	6 months

Trial Locations

Locations (1)

Federico II University; 🇮🇹 Naples, Italy