20070360 Incident Dialysis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-01

Study Completion Date

2011-07-05

Brief Summary

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Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

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Detailed Description

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Conditions

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Chronic Kidney Disease Secondary Hyperparathyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cinacalcet Group

Cinacalcet plus low dose active Vitamin D (if prescribed)

Group Type EXPERIMENTAL

Cinacalcet

Intervention Type DRUG

Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt.

Control Group

Flexible active vitamin D dosing

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.

Interventions

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Cinacalcet

Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt.

Intervention Type DRUG

Vitamin D

Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.

Intervention Type DRUG

Other Intervention Names

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Sensipar/Mimpara Active Vitamin D

Eligibility Criteria

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Inclusion Criteria

* Adults greater than or equal to 18 years of age on hemodialysis for \> 3 and less than or equal to 12 months prior to enrollment into the study
* Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) \> 300 pg/mL (31.8 pmol/L); or biPTH \> 160 pg/mL (17.0 pmol/L)
* Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
* Subject will be able to complete the study, to the best of his/her knowledge
* Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria

* Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) \> 800 pg/mL (84.9 pmol/L); or biPTH \> 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
* Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
* Anticipated parathyroidectomy (partial or full) within 6 months after randomization
* Have a scheduled date for kidney transplant surgery
* Received cinacalcet since initiating hemodialysis
* Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
* Subject is pregnant (eg, positive HCG test) or is breast-feeding
* Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
* Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
* Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
* Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
* Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No