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

Completed · Phase 4

Conditions studied: Chronic Kidney Disease, Secondary Hyperparathyroidism, Hemodialysis

In brief

Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.

Key facts

Study ID

NCT00977080

Run by

Abbott

People needed

272

Starts

2009-11-01

Expected to finish

2011-05-01

Last updated by the study team

2012-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients >= 18 years old.
• 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.
• 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.
• 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)

You may not qualify if…

• Patient had a history of parathyroidectomy.
• 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.
• 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.
• Patient was known to be human immunodeficiency (HIV) positive.

Where it is running

• Site Reference ID/Investigator# 24342 — Chula Vista, California, United States
• Site Reference ID/Investigator# 21142 — Los Angeles, California, United States
• Site Reference ID/Investigator# 22762 — Los Angeles, California, United States
• Site Reference ID/Investigator# 22758 — Riverside, California, United States
• Site Reference ID/Investigator# 21442 — San Diego, California, United States
• Site Reference ID/Investigator# 23688 — Arvada, Colorado, United States
• Site Reference ID/Investigator# 21370 — Coral Springs, Florida, United States
• Site Reference ID/Investigator# 25902 — Hudson, Florida, United States
• Site Reference ID/Investigator# 21146 — Lauderdale Lakes, Florida, United States
• Site Reference ID/Investigator# 26743 — Lauderdale Lakes, Florida, United States
• Site Reference ID/Investigator# 22788 — Miami, Florida, United States
• Site Reference ID/Investigator# 22722 — Orlando, Florida, United States
• Site Reference ID/Investigator# 23147 — Tampa, Florida, United States
• Site Reference ID/Investigator# 22778 — Meridian, Idaho, United States
• Site Reference ID/Investigator# 21369 — Detroit, Michigan, United States
• Site Reference ID/Investigator# 22786 — Detroit, Michigan, United States
• Site Reference ID/Investigator# 21144 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 21443 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 21145 — Omaha, Nebraska, United States
• Site Reference ID/Investigator# 22505 — Flushing, New York, United States
• Site Reference ID/Investigator# 22759 — Toledo, Ohio, United States
• Site Reference ID/Investigator# 22796 — Lancaster, Pennsylvania, United States
• Site Reference ID/Investigator# 22770 — Philadelphia, Pennsylvania, United States
• Site Reference ID/Investigator# 22772 — Aiken, South Carolina, United States
• Site Reference ID/Investigator# 22781 — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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