Overview

Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
Summary
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Abbott
Treatments:
Alfacalcidol
Cinacalcet
Cinacalcet Hydrochloride
Ergocalciferols
Vitamin D
Vitamins
Criteria
Inclusion Criteria

1. Male or female patients >= 18 years old.

2. Patient was diagnosed with Stage 5 chronic kidney disease (CKD) and had been receiving
intravenous (IV) or oral vitamin D receptor activators (VDRAs) or cinacalcet during
the 8 weeks prior to the screening period or naïve patients who had not received VDRA
or cinacalcet within 8 weeks of screening.

3. Patient was on maintenance HD (hemodialysis) 3 times weekly (TIW) for at least 3
months prior to screening and was expected to remain on HD for the duration of the
study.

4. For entry into the Pre-Treatment Washout Period (for patients who were not naïve to
VDRAs and cinacalcet), the patient had to have screening laboratory values of:

- iPTH level 130 to 700 pg/mL

- Serum Total Alkaline Phosphatase level >= 40 U/L

- Calcium level <= 10.0 mg/dL (2.49 mmol/L)

- Calcium-phosphorus product (CaxP) <= 75 mg2/dL2 (US) and <= 70 mg2/dL2 (non-US)

Exclusion Criteria

1. Patient had a history of parathyroidectomy.

2. Patient had a current malignancy (with the exception of basal or squamous cell
carcinoma of the skin), or clinically significant liver disease, in the opinion of the
investigator.

3. Use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of
cytochrome P450 (including grapefruit and/or grapefruit juice) 3A (CYP3A) or drugs
metabolized by cytochrome P450 2D6 (CYP2D6) (e.g., flecainide, vinblastine,
thioridazine, and most tricyclic antidepressants) within 2 weeks prior to study drug
administration. Commonly used beta blockers such as metoprolol and carvedilol are
allowed but are metabolized by CYP2D6; thus, an adjustment to a lower dose may have
been required.

4. Patient was known to be human immunodeficiency (HIV) positive.