ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism

Study Overview
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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.

Official Title
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ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Sensipar® and Low Dose Vitamin D vs. Escalating Doses of Vitamin D Alone

Conditions
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Secondary Hyperparathyroidism

Intervention / Treatment
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* Drug: Sensipar®
* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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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 8.4 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cinacalcet and low-dose Vitamin D<br>Cinacalcet and low-dose IV Vitamin D | Drug: Sensipar®<br>* Cinacalcet hydrochloride<br>* Other names: Cinacalcet hydrochloride, Cinacalcet HCL, Cinacalcet;Drug: Vitamin D<br>* Vitamin D administered IV<br>* Other names: paricalcitol, doxercalciferol;|
| Active Comparator: Vitamin D alone<br>Escalating doses of IV Vitamin D alone | Drug: Vitamin D<br>* Vitamin D administered IV<br>* Other names: paricalcitol, doxercalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving the NKF-K/DOQI targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (less than 55 mg^2/dL^2) during the assessment phase | Proportion of subjects in each treatment group simultaneously achieving the National Kidney Foundation - Kidney Disease Outcome Quality Initiative (NKF-K/DOQI) targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (< 55 mg^2/dL^2) during the assessment phase (last 11 weeks of study following a 16-week titration phase) | Weeks 17 - 27 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change from Baseline for P During the Assessment Phase | Absolute change from baseline for serum phosphorus (P) during the assessment phase | Baseline to weeks 17-27 | 
| Proportion of Participants with ≥ 30% Reduction from Baseline in Mean iPTH During the Assessment Phase | Proportion of participants with ≥ 30% reduction from baseline in mean intact parathyroid hormone (iPTH) during the assessment phase. | Baseline and Weeks 17-27 | 
| Percent Change from Baseline for Calcium During the Assessment Phase | Percent Change from Baseline for Calcium (Ca) During the Assessment Phase | Baseline to weeks 17-27 | 
| Percent Change from Baseline for Phosphorus During the Assessment Phase | Percent change from baseline for Phosphorus (P) during the assessment phase | Baseline to weeks 17-27 | 
| Percent Change from Baseline for Ca x P During the Assessment Phase | Percent change from baseline for calcium x phosphorus (Ca x P) during the assessment phase | Baseline to weeks 17-27 | 
| Percent Change from Baseline for iPTH During the Assessment Phase | Percent change from baseline for intact parathyroid hormone (iPTH) during the assessment phase | Baseline to weeks 17-27 | 
| Proportion of Participants who Attained the K/DOQI Target Range for Ca x P During the Assessment Phase. | Proportion of participants who attained the K/DOQI target range for calcium x phosphorus (Ca x P) during the assessment phase. | Weeks 17 - 27 | 
| Proportion of Participants who Attained the K/DOQI Target Range for Ca During the Assessment Phase | Proportion of participants who attained the K/DOQI target range for calcium (Ca) during the assessment phase. | Weeks 17-27 | 
| Proportion of Participants who Attained the K/DOQI Target Range for iPTH During the Assessment Phase | Proportion of participants who attained the K/DOQI target range for intact parathyroid hormone (iPTH) during the assessment phase. | Weeks 17-27 | 
| Proportion of Participants who Attained the K/DOQI Target Range for P During the Assessment Phase. | Proportion of participants who attained the K/DOQI target range for phosphorus (P) during the assessment phase. | Weeks 17-27 | 
| Absolute Change from Baseline for iPTH During the Assessment Phase | Absolute change from baseline for intact parathyroid hormone (iPTH) during the assessment phase. | Baseline to weeks 17-27 | 
| Absolute Change from Baseline for Ca During the Assessment Phase | Absolute change from baseline for calcium (Ca) during the assessment phase | Baseline to weeks 17-27 | 
| Absolute Change from Baseline for Ca x P During the Assessment Phase | Absolute change from baseline for calcium x phosphorus (Ca x P) during the assessment phase. | Baseline to weeks 17-27 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Sensipar®, Cinacalcet HCl, Chronic Kidney Disease