Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Cinacalcet; Cinacalcet Hydrochloride

Criteria

Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following criteria:

• One Intact Parathyroid Hormone (iPTH) determination obtained from the central laboratory must be >/= 300 pg/mL.

• One serum calcium determination obtained from the central laboratory must be >/= 8.4 mg/dL (2.1 mmol/L).

• One Bone Alkaline Phosphatase (BALP) determination obtained from the central laboratory must be >/= 20.9 ng/mL.

• Positive histologic confirmation of high bone turnover disease as assessed by the central bone histology center.

• Treated with dialysis >/= 1 month before the date of informed consent.

Exclusion Criteria: Subjects will be ineligible for the study if they:

• Have an unstable medical condition in the judgment of the investigator.

• Are pregnant or nursing women.

• Had a parathyroidectomy in the 3 months before the date of informed consent.

• For subjects prescribed vitamin D, have received vitamin D therapy for less than 30 days before day 1 or required a change in vitamin D brand or dose level within 30 days before day 1.

• Ever received therapy with Sensipar®/Mimpara®