12-month Study of AMG 073 in Renal Osteodystrophy

Renal Osteodystrophy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527085
• Other study ID #: 20010141
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2007
• Last updated: May 6, 2013
• Start date: October 2001
• Est. completion date: August 2003

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Osteodystrophy

Intervention

Drug:
• AMG 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
• Placebo
30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Malluche HH, Monier-Faugere MC, Wang G, Frazã O JM, Charytan C, Coburn JW, Coyne DW, Kaplan MR, Baker N, McCary LC, Turner SA, Goodman WG. An assessment of cinacalcet HCl effects on bone histology in dialysis patients with secondary hyperparathyroidism. C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry		entire study	No
Secondary	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	No
Secondary	To evaluate the feasibility of measuring physical activity with accelerometry		entire study	No
Secondary	To evaluate the safety and tolerability of AMG 073 compared with placebo		entire study	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling