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Paricalcitol Effect on Anemia in CKD

This study has been completed.
Information provided by (Responsible Party):
Eleonora Riccio, Federico II University Identifier:
First received: January 13, 2013
Last updated: July 29, 2014
Last verified: November 2012
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.

Condition Intervention Phase
Chronic Kidney Disease
Drug: Paricalcitol
Drug: Calcitriol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease

Resource links provided by NLM:

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Modification in hemoglobin levels [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Modifications in urinary protein excretion [ Time Frame: 6 months ]

Enrollment: 60
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
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.
Drug: Calcitriol
Rocaltrol cp 0,5 mcg every other day per os
Other Name: Rocaltrol
Experimental: 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.
Drug: Paricalcitol
Zemplar cp 1 mcg/day per os
Other Name: Zemplar

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01768351

Federico II University
Naples, Italy, 80129
Sponsors and Collaborators
Federico II University
Principal Investigator: Eleonora Riccio, MD
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eleonora Riccio, MD, Federico II University Identifier: NCT01768351     History of Changes
Other Study ID Numbers: PCX1234
paranemia ( Other Identifier: Federico II University of Naples )
Study First Received: January 13, 2013
Last Updated: July 29, 2014

Keywords provided by Federico II University:
chronic kidney disease
vitamin D

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 28, 2017