Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Amgen54 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Secondary Hyperparathyroidism Chronic Renal Insufficiency

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

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