CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 65 enrolled
Drug / intervention
Paricalcitol +1 moredrug
Likely dose
Darbepoetin alfa 200 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01506947
NCT01506947Phase 4Completed
CompareCT.gov

A Prospective, Non-randomised, Single-arm, Open-Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients

AbbVie (prior sponsor, Abbott)·interventional·Posted Jan 10, 2012·Updated Jul 30, 2021

In Brief

A Phase 4 clinical trial evaluating Paricalcitol and Darbepoetin alfa for Moderate to Severe Secondary Hyperparathyroidism and Stage 5 Chronic Kidney Diseases. Completed, enrolled 65 participants.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate to Severe Secondary Hyperparathyroidism, Stage 5 Chronic Kidney Diseases
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2012
Enrollment StartMay 10, 2012
Primary CompletionApr 7, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.5 years ago

Interventions

Paricalcitoldrug

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.

Darbepoetin alfadrug

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.