Back to resultsParicalcitol Effect on Anemia in CKD
Primary Purpose
Anemia, Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Paricalcitol
Calcitriol
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring anemia, chronic kidney disease, vitamin D, paricalcitol, hyperparathyroidism
Eligibility 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
Sites / Locations
- Federico II University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Paricalcitol
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Modification in hemoglobin levels
Secondary Outcome Measures
Modifications in urinary protein excretion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01768351
Brief Title
Paricalcitol Effect on Anemia in CKD
Official Title
Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Kidney Disease
Keywords
anemia, chronic kidney disease, vitamin D, paricalcitol, hyperparathyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Paricalcitol
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Paricalcitol
Other Intervention Name(s)
Zemplar
Intervention Description
Zemplar cp 1 mcg/day per os
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Other Intervention Name(s)
Rocaltrol
Intervention Description
Rocaltrol cp 0,5 mcg every other day per os
Primary Outcome Measure Information:
Title
Modification in hemoglobin levels
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Modifications in urinary protein excretion
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleonora Riccio, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federico II University
City
Naples
ZIP/Postal Code
80129
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
25781618
Citation
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.
Results Reference
derived
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Paricalcitol Effect on Anemia in CKD
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