12-month Study of AMG 073 in Renal Osteodystrophy

A Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Study to Assess the Effects of an Oral Calcimimetic Agent (AMG 073) on Renal Osteodystrophy in Hemodialysis Patients With Secondary Hyperparathyroidism

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00527085

Enrollment

Registered

2007-09-10

Start date

2001-10-31

Completion date

2003-08-31

Last updated

2013-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Osteodystrophy

Brief 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.

Interventions

DRUGAMG 073

30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

DRUGPlacebo

30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry	entire study

Secondary

Measure	Time frame
To evaluate the effects of AMG 073 compared with placebo on intact parathyroid hormone (iPTH), bone-specific alkaline phosphatase (BALP), serum N-Telopeptide (N-Tx), and calcium x phosphorus product concentrations	entire study
To evaluate the feasibility of measuring physical activity with accelerometry	entire study
To evaluate the safety and tolerability of AMG 073 compared with placebo	entire study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026