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Paricalcitol Effect on Anemia in CKD

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ClinicalTrials.gov Identifier: NCT01768351
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):
Eleonora Riccio, Federico II University

Tracking Information
First Submitted Date  ICMJE January 13, 2013
First Posted Date  ICMJE January 15, 2013
Last Update Posted Date July 30, 2014
Study Start Date  ICMJE October 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2013)
Modification in hemoglobin levels [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
Modifications in urinary protein excretion [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paricalcitol Effect on Anemia in CKD
Official Title  ICMJE Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Paricalcitol
    Zemplar cp 1 mcg/day per os
    Other Name: Zemplar
  • Drug: Calcitriol
    Rocaltrol cp 0,5 mcg every other day per os
    Other Name: Rocaltrol
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Calcitriol
  • 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.
    Intervention: Drug: Paricalcitol
Publications * Riccio E, Sabbatini M, Bruzzese D, Capuano I, Migliaccio S, Andreucci M, Pisani A. Effect of paricalcitol vs calcitriol on hemoglobin levels in chronic kidney disease patients: a randomized trial. PLoS One. 2015 Mar 17;10(3):e0118174. doi: 10.1371/journal.pone.0118174. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2013)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01768351
Other Study ID Numbers  ICMJE PCX1234
paranemia ( Other Identifier: Federico II University of Naples )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eleonora Riccio, Federico II University
Study Sponsor  ICMJE Federico II University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eleonora Riccio, MD
PRS Account Federico II University
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP