A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis

End Stage Renal Disease Clinical Trial

Official title:

A Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of Chronic Kidney Disease (Hemodialysis and Peritoneal Dialysis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042653
• Other study ID #: 20000188
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2002
• Last updated: May 6, 2013
• Start date: May 2002
• Est. completion date: July 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

This 6 month study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: July 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Patients must be receiving hemodialysis; have elevated parathyroid hormone levels; not be pregnant or nursing; and not have had a heart attack in the last 3 months.

Study Design

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• Placebo
30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken once daily orally
• AMG 073
30 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Lindberg JS, Culleton B, Wong G, Borah MF, Clark RV, Shapiro WB, Roger SD, Husserl FE, Klassen PS, Guo MD, Albizem MB, Coburn JW. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase.		Efficacy Assessment phase - final 10 weeks of study	No
Secondary	To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in mean iPTH of >= 30% during the efficacy assessment phase		Efficacy Assessment phase - final 10 weeks of study	No
Secondary	To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during the efficacy assessment phase		Efficacy Assessment phase - final 10 weeks of study	No
Secondary	To evaluate the safety of AMG 073 compared with placebo		Entire study - 26 weeks	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling