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Completed

NCT Number: NCT00527085

12-month Study of AMG 073 in Renal Osteodystrophy

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.

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Key information

Conditions

Renal Osteodystrophy Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Chronic Disease Chronic Kidney Disease-Mineral and Bone Disorder Deficiency Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rickets Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 073

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: entire study

Secondary outcomes

  1. 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

  2. To evaluate the feasibility of measuring physical activity with accelerometry

    Time frame: entire study

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

    Time frame: entire study

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Sep 10, 2007
Registry last updated
May 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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