Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

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

Completed

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Key information

Conditions

Secondary Hyperparathyroidism Chronic Disease Chronic Renal Insufficiency Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cinacalcet (AMG 073)

Drug

Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.

Primary outcomes

Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase

Time frame: Efficacy assessment phase (weeks 12-18)

Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase

Secondary outcomes

Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase

Time frame: Baseline, efficacy assessment phase (weeks 12-18)

Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Aug 1, 2002
Registry last updated: May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed