Status:
COMPLETED
20070360 Incident Dialysis
Lead Sponsor:
Amgen
Conditions:
Chronic Kidney Disease
Secondary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Ini...
Eligibility Criteria
Inclusion
- Adults greater than or equal to 18 years of age on hemodialysis for \> 3 and less than or equal to 12 months prior to enrollment into the study
- Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) \> 300 pg/mL (31.8 pmol/L); or biPTH \> 160 pg/mL (17.0 pmol/L)
- Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
- Subject will be able to complete the study, to the best of his/her knowledge
- Before any study-specific procedure, the appropriate written informed consent must be obtained
Exclusion
- Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) \> 800 pg/mL (84.9 pmol/L); or biPTH \> 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
- Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
- Anticipated parathyroidectomy (partial or full) within 6 months after randomization
- Have a scheduled date for kidney transplant surgery
- Received cinacalcet since initiating hemodialysis
- Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
- Subject is pregnant (eg, positive HCG test) or is breast-feeding
- Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
- Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
- Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
- Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
- Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2011
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT00803712
Start Date
February 1 2009
End Date
July 5 2011
Last Update
October 17 2018
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