Paricalcitol Effect on Anemia in CKD

NCT01768351 | Completed Phase 4

• 2 other identifiers: PCX1234paranemia
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Chronic Kidney Disease

Keywords

anemia; chronic kidney disease; vitamin D; paricalcitol; hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Modification in hemoglobin levels

  6 months

Secondary Outcomes (1)

• Modifications in urinary protein excretion

  6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Paricalcitol

EXPERIMENTAL

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

Interventions

Paricalcitol DRUG

Zemplar cp 1 mcg/day per os

Also known as: Zemplar

Paricalcitol

Calcitriol DRUG

Rocaltrol cp 0,5 mcg every other day per os

Also known as: Rocaltrol

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University

Naples, 80129, Italy

Location

Related Publications (1)

• 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.

  PMID: 25781618 DERIVED

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Hyperparathyroidism

Interventions

paricalcitol; Calcitriol

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Eleonora Riccio, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 13, 2013
• First Posted: January 15, 2013
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: October 1, 2012
• Last Updated: July 30, 2014

Record last verified: 2012-11

Locations

IT (1)