12-month Study of AMG 073 in Renal Osteodystrophy

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

Summary

4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.

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

Details

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

Criteria

Inclusion Criteria:

• 18 years of age of greater

• Using effective contraceptive measures

• iPTH greater than or equal to 300 pg/mL

• Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9

• Stable hemodialysis for 1 month prior to day 1

Exclusion Criteria:

• Any unstable medical condition

• Pregnant or nursing women Recent parathyroidectomy

• Change in Vitamin D therapy

• Recent MI, Seizure, Malignancy, GI Disorder

• Inability to swallow tablets