Trials / Completed
CompletedNCT01506947
A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
A Prospective, Non-randomised, Single-arm, Open-Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- AbbVie (prior sponsor, Abbott) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-05-10
- Primary completion
- 2016-04-07
- Completion
- 2016-04-07
- First posted
- 2012-01-10
- Last updated
- 2021-07-30
- Results posted
- 2017-05-15
Source: ClinicalTrials.gov record NCT01506947. Inclusion in this directory is not an endorsement.