12-month Study of AMG 073 in Renal Osteodystrophy

Amgen45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Renal Osteodystrophy

Interventions

AMG 073DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry

Time frame: entire study

Secondary Outcomes

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

Time frame: entire study

To evaluate the feasibility of measuring physical activity with accelerometry

Time frame: entire study

To evaluate the safety and tolerability of AMG 073 compared with placebo

Time frame: entire study

Data from ClinicalTrials.gov

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