Clinical trial NCT01768351: Paricalcitol Effect on Anemia in CKD
Official title: Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Chronic Kidney Disease
Keywords: anemia
chronic kidney disease
vitamin D
paricalcitol
hyperparathyroidism
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Modification in hemoglobin levels
timeFrame: 6 months
Secondary outcomes:
measure: Modifications in urinary protein excretion
timeFrame: 6 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University
Study officials:
name: Eleonora Riccio, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.