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Study Complete
Sponsor ID
20090686

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

Sponsor ID
20090686
Clinicaltrials.gov ID
NCT01181531
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.

Additional Study Details

Phase
Phase 4
Product
cinacalcet hcl
Type
Interventional
Masking
None (Open Label)
Enrollment
312
Additional Study Details

Protocol Summary

Primary Outcome Measures

To demonstrate the efficacy of treatment with cinacalcet compared to traditional vitamin D therapy, given orally or intravenously (IV), for controlling plasma parathyroid hormone(PTH) levels among hemodialysis subjects with secondary hyperparathyroidism

Timeframe: 1 year

Secondary Outcome Measures

To demonstrate a clinically meaningful reduction in plasma parathyroid hormone levels after 1 year of treatment with cinacalcet compared with traditional vitamin D therapy

Timeframe: 1 year

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Hyperparathyroidism
    • Sex
    All
    Trial Dates
    Oct 2010 - Jul 2012
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Age ≥ 18 years at screening - Treated with maintenance hemodialysis 3 times a week for ≥ 3 months prior to screening - Informed consent provided by the study candidate - For subjects NOT receiving cinacalcet and/or vitamin D therapy for SHPT within 60 days prior to enrollment: Plasma PTH levels ≥ 450 pg/mL (50 pmol/L) during screening, as obtained from the central laboratory and, Serum corrected total calcium ≥ 8.4 mg/dL (2.1 mmol/L) and < 10.2 mg/dL (2.55 mmol/L) during screening, as obtained from the central laboratory
    Exclusion Criteria:
    - Parathyroidectomy in the 12 weeks before the date of informed consent - History of seizure within 12 weeks prior to randomization - Scheduled for kidney transplant - Parathyroidectomy anticipated within the next 6 months - Liver function tests > than 2 x the Upper Limit of Normal - Prior use of bisphosphonates, or expected to receive bisphosphonates during the trial - Subject has previously enrolled in this study - General -Other investigational procedures are excluded -Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) -Subject (male or female) is not willing to use highly effective contraception during treatment and for at least one month (women) and 3 months (men) after the end of treatment -Subject is pregnant or breast feeding, or planning to become pregnant during study or within 1 month after the end of treatment Male subject with a pregnant partner who is not willing to use a condom during treatment and for at least 1 month after the end of treatment -Subject has known sensitivity or intolerance to any of the protocol required therapies -Subject will not be available for protocol-required study visits, to the best of the subject and investigator’s knowledge -Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures