Status:
COMPLETED
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
Lead Sponsor:
Amgen
Conditions:
Hyperparathyroidism, Secondary
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 intravenou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2012
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT01181531
Start Date
October 1 2010
End Date
August 14 2012
Last Update
October 17 2018
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