Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Amgen

Status and phase: Completed; Phase 2

Conditions: Chronic Renal Insufficiency; Secondary Hyperparathyroidism

Treatments: Drug: cinacalcet (AMG 073)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00042432

20010239

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups, including a placebo group

cinacalcet (AMG 073)

Experimental group

Treatment:

Drug: cinacalcet (AMG 073)

Placebo

Placebo Comparator group

Treatment:

Drug: cinacalcet (AMG 073)