Phase 4 N=552 Randomized Treatment

A Research Study for Patients With End-Stage Renal Disease (ESRD)

End Stage Renal Disease

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View on ClinicalTrials.gov: NCT00110890 ↗

Enrolled (actual)

552

Serious AEs

20.8%

Results posted

Mar 2011

Primary outcome: Primary: Number of Participants With Mean PTH ≤ 300 pg/mL — 262; 41 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: cinacalcet (Drug); Standard of care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Apr 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Mean PTH ≤ 300 pg/mL	262; 41	<0.001 sig
SECONDARY Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL	217; 29	<0.001 sig
SECONDARY Number of Participants With Mean Ca x P < 55 mg^2/dL^2	282; 106	<0.001 sig
SECONDARY Number of Participants With Mean Serum Ca < 9.5 mg/dL	281; 61	<0.001 sig
SECONDARY Number of Participants With Mean Serum P < 5.5 mg/dL	231; 92	0.002 sig

Summary

The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.

Eligibility Criteria

Inclusion Criteria

ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
The mean of 2 iPTH determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L)
The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be greater than or equal to 8.4 mg/dL (2.1 mmol/L)

Exclusion Criteria

Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
Have had a parathyroidectomy in the 6 months before day 1
Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1.
Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). The tricyclic antidepressant amitriptyline is permitted. - Experienced a myocardial infarction within 3 months prior to day 1
Are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
Have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets

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Data sourced from ClinicalTrials.gov (NCT00110890). 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.