Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Phase 2

Completed

• Conditions: Secondary Hyperparathyroidism; Chronic Renal Insufficiency
• Interventions: Drug: cinacalcet (AMG 073)

• Registration Number: NCT00042432
• Lead Sponsor: Amgen

Brief Summary

This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-07-29
• Study First Submitted QC: 2002-07-31
• Study First Posted: 2002-08-01
• Primary Completion: 2003-03
• Study Completion: 2003-08
• Results First Submitted: 2010-11-04
• Results First Submitted QC: 2011-02-04
• Results First Posted: 2011-03-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients must have chronic renal insufficiency (pre-dialysis)
• Have below normal creatinine clearance
• Have elevated parathyroid hormone levels

Exclusion Criteria

• Pregnant or nursing
• Heart attack in the last 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cinacalcet (AMG 073)	cinacalcet (AMG 073)	-
Placebo	cinacalcet (AMG 073)	-

Primary Outcome Measures

Name	Time	Method
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase	Efficacy assessment phase (weeks 12-18)	Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase	Baseline, efficacy assessment phase (weeks 12-18)	Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase