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Paricalcitol Effect on Anemia in CKD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01768351
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : July 30, 2014
Information provided by (Responsible Party):
Eleonora Riccio, 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.

Condition or disease Intervention/treatment Phase
Anemia Chronic Kidney Disease Drug: Paricalcitol Drug: Calcitriol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease
Study Start Date : October 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01768351

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Federico II University
Naples, Italy, 80129
Sponsors and Collaborators
Federico II University
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Principal Investigator: Eleonora Riccio, MD
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eleonora Riccio, MD, Federico II University Identifier: NCT01768351    
Other Study ID Numbers: PCX1234
paranemia ( Other Identifier: Federico II University of Naples )
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: November 2012
Keywords provided by Eleonora Riccio, Federico II University:
chronic kidney disease
vitamin D
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents