Phase 2 N=54 Randomized Triple-blind Treatment

Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Secondary Hyperparathyroidism · Chronic Renal Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT00042432 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Mar 2011

Primary outcome: Primary: Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase — 15; 5 Participants — p=0.006

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cinacalcet (AMG 073) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Mar 2003

Outcome Measures

Outcome	Result	p-value
PRIMARY Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase	15; 5	0.006 sig
SECONDARY Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase	-31.5; 5.8	<0.001 sig

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00042432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.