Paricalcitol Effect on Anemia in CKD

NCT ID: NCT01768351

Last Updated: 2014-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Anemia; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Calcitriol

Intervention Type: DRUG

Rocaltrol cp 0,5 mcg every other day per os

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.

Group Type: EXPERIMENTAL

Paricalcitol

Intervention Type: DRUG

Zemplar cp 1 mcg/day per os

Interventions

Paricalcitol

Zemplar cp 1 mcg/day per os

Intervention Type: DRUG

Calcitriol

Rocaltrol cp 0,5 mcg every other day per os

Intervention Type: DRUG

Other Intervention Names

Zemplar; Rocaltrol

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Eleonora Riccio

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eleonora Riccio, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Federico II University

Naples, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 25781618 (View on PubMed)

Other Identifiers

paranemia

Identifier Type: OTHER

Identifier Source: secondary_id

PCX1234

Identifier Type: -

Identifier Source: org_study_id