20070360 Incident Dialysis

• Status: Completed
• Trial end date: 2011-07-05
• Target enrollment: 0
• Participant gender: All

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 Initiating Hemodialysis

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Cinacalcet; Cinacalcet Hydrochloride; Ergocalciferols; Vitamin D; Vitamins

Criteria

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).