Paricalcitol Effect on Anemia in CKD

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Treatments: Calcitriol; Ergocalciferols

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