Conditions: Moderate to Severe Secondary Hyperparathyroidism Stage 5 Chronic Kidney Diseases
Keywords: Hemodialysis Chronic kidney disease Secondary hyperparathyroidism,
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 65
Healthy volunteers: no

Brief summary:
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.

Detailed description:

Arms:
arm 1: Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Interventions: intervention 1: Paricalcitol intervention 2: Darbepoetin alfa
Intervention descriptions: intervention 1: Paricalcitol was administered by intravenous bolus. The initial dose was calculated according to the following formula:

\[Paricalcitol (µg) = iPTH (pg/mL) / 80\]. Subsequent doses were determined based on iPTH, calcium and phosphorus levels. intervention 2: Routine darbepoetin alfa use was allowed when transferrin saturation (TSAT) was ≥ 20% and ferritin ≥ 200 μg/L, and hemoglobin level \< 11.5 g/dL. The initial dose was 0.25 to 0.75 µg/kg/week, and the maintenance dose was 0.13 to 0.35 µg/kg/week. Target hemoglobin level was between 10 to 11.5 g/dL.

Protocol document: