Paricalcitol Effect on Anemia in CKD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eleonora Riccio, Federico II University
ClinicalTrials.gov Identifier:
NCT01768351
First received: January 13, 2013
Last updated: July 29, 2014
Last verified: November 2012

January 13, 2013
July 29, 2014
October 2010
March 2011   (final data collection date for primary outcome measure)
Modification in hemoglobin levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01768351 on ClinicalTrials.gov Archive Site
Modifications in urinary protein excretion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Paricalcitol Effect on Anemia in CKD
Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anemia
  • Chronic Kidney Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2012
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01768351
PCX1234, paranemia
No
Eleonora Riccio, Federico II University
Federico II University
Not Provided
Principal Investigator: Eleonora Riccio, MD
Federico II University
November 2012

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