12-month Study of AMG 073 in Renal Osteodystrophy

Amgen

Status and phase: Completed; Phase 2

Conditions: Renal Osteodystrophy

Treatments: Drug: Placebo; Drug: AMG 073

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527085

20010141

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

AMG 073

Experimental group

Treatment:

Drug: AMG 073

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo