A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

May 10, 2012

Primary Completion Date

April 7, 2016

Study Completion Date

April 7, 2016

Conditions
Moderate to Severe Secondary HyperparathyroidismStage 5 Chronic Kidney Diseases
Interventions
DRUG

Paricalcitol

"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."

DRUG

Darbepoetin alfa

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.

All Listed Sponsors
lead

AbbVie (prior sponsor, Abbott)

INDUSTRY

NCT01506947 - A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients | Biotech Hunter | Biotech Hunter