Status:
COMPLETED
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Lead Sponsor:
Abbott
Conditions:
Chronic Kidney Disease
Secondary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
Detailed Description
During a 4-week washout period, participants stopped taking cinacalcet or other vitamin D receptor activators (VDRAs). (Participants who were naive to cinacalcet or VDRAs did not have to wash out). At...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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)
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT00977080
Start Date
November 1 2009
End Date
May 1 2011
Last Update
June 20 2012
Active Locations (83)
Enter a location and click search to find clinical trials sorted by distance.
1
Site Reference ID/Investigator# 22781
Tempe, Arizona, United States, 85284
2
Site Reference ID/Investigator# 24342
Chula Vista, California, United States, 91910
3
Site Reference ID/Investigator# 21142
Los Angeles, California, United States, 90033
4
Site Reference ID/Investigator# 22762
Los Angeles, California, United States, 90048