ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-12-31

Brief Summary

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The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P) product.

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Detailed Description

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Conditions

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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 and low-dose Vitamin D

Cinacalcet and low-dose IV Vitamin D

Group Type EXPERIMENTAL

Sensipar®

Intervention Type DRUG

Cinacalcet hydrochloride

Vitamin D

Intervention Type DRUG

Vitamin D administered IV

Vitamin D alone

Escalating doses of IV Vitamin D alone

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

Vitamin D administered IV

Interventions

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Sensipar®

Cinacalcet hydrochloride

Intervention Type DRUG

Vitamin D

Vitamin D administered IV

Intervention Type DRUG

Other Intervention Names

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Cinacalcet hydrochloride, Cinacalcet HCL, Cinacalcet paricalcitol, doxercalciferol

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - On hemodialysis for at least 3 months and have received intravenous vitamin D therapy (paricalcitol or doxercalciferol) for at least 3 months prior to entering screening - Historical iPTH 150-800 pg/ml (or biPTH 80-430 pg/ml) within 6 months and corrected serum Ca greater than 8.4 mg/dl within 2 months prior to screening period. For subjects with biPTH 80-160 pg/ml (iPTH 150-300 pg/ml), Ca x P must be greater than 55 mg²/dl² within 2 months prior to the screening period - Screening (pre-washout) biPTH 80-430 pg/ml and a corrected serum Ca level greater than 8.4 mg/dl. For subjects with biPTH 80-160 pg/ml Ca x P must be also greater than 55 mg²/dl² - Baseline mean biPTH (post-washout) greater than 160 pg/ml and mean corrected Ca greater than 8.

Exclusion Criteria

4 mg/dl Exclusion Criteria: - Parathyroidectomy in the 3 month period prior to screening - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets - Use of investigational drug or device or participation in a trial of investigational drug or device within 30 days of screening - Females of child bearing potential who are pregnant (e.g., positive pregnancy test) or are breast feeding or who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study - Previously participated in this or any other Sensipar® study or has received or is receiving Sensipar® as a commercially available product

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No