Paricalcitol Effect on Anemia in CKD

Anemia Clinical Trial

Official title:

Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768351
• Other study ID #: PCX1234
• Secondary ID: paranemia
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2013
• Last updated: July 29, 2014
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Paricalcitol
Zemplar cp 1 mcg/day per os
• Calcitriol
Rocaltrol cp 0,5 mcg every other day per os

Locations

Country	Name	City	State
Italy	Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification in hemoglobin levels		6 months	No
Secondary	Modifications in urinary protein excretion		6 months	No