Paricalcitol Effect on Anemia in CKD

Federico II University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Anemia

Treatments: Drug: Paricalcitol; Drug: Calcitriol

Study type: Interventional

Funder types: Other

Identifiers

NCT01768351

paranemia (Other Identifier)

PCX1234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Calcitriol

Paricalcitol

Experimental group

Description:

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.

Treatment:

Drug: Paricalcitol