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
  Purpose

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
Anemia
Chronic Kidney Disease
Drug: Paricalcitol
Drug: Calcitriol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modifications in urinary protein excretion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01768351

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

No publications provided

Responsible Party: Eleonora Riccio, MD, Federico II University
ClinicalTrials.gov Identifier: NCT01768351     History of Changes
Other Study ID Numbers: PCX1234, paranemia
Study First Received: January 13, 2013
Last Updated: July 29, 2014
Health Authority: Italy: National Bioethics Committee

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

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Calcitriol
Ergocalciferols
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014