20070360 Incident Dialysis

Amgen

Status and phase

Completed

Phase 4

Conditions

Chronic Kidney Disease

Secondary Hyperparathyroidism

Treatments

Drug: Cinacalcet

Drug: Vitamin D

Study type

Interventional

Funder types

Industry

Identifiers

NCT00803712

20070360

Details and patient eligibility

About

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 Initiating Hemodialysis

Enrollment

313 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).