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

NCT01506947 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-07-30

Study results available
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Summary

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

Conditions

  • Moderate to Severe Secondary Hyperparathyroidism
  • Stage 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.

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Mahmut Gücük, MD · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-10
Primary Completion
2016-04-07
Completion
2016-04-07

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01506947 on ClinicalTrials.gov