Paricalcitol Effect on Anemia in CKD

Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01768351

Enrollment

Registered

2013-01-15

Start date

2010-10-31

Completion date

2012-10-31

Last updated

2014-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Chronic Kidney Disease

Keywords

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

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.

Interventions

DRUGParicalcitol

Zemplar cp 1 mcg/day per os

DRUGCalcitriol

Rocaltrol cp 0,5 mcg every other day per os

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Modification in hemoglobin levels	6 months

Secondary

Measure	Time frame
Modifications in urinary protein excretion	6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026