ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00135304
First received: August 24, 2005
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Secondary Hyperparathyroidism
Drug: Sensipar®
Drug: Vitamin D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Sensipar® and Low Dose Vitamin D vs. Escalating Doses of Vitamin D Alone

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 [ Time Frame: Weeks 17 - 27 ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Absolute Change from Baseline for P During the Assessment Phase [ Time Frame: Baseline to weeks 17-27 ] [ Designated as safety issue: No ]
    Absolute change from baseline for serum phosphorus (P) during the assessment phase

  • Proportion of Participants with ≥ 30% Reduction from Baseline in Mean iPTH During the Assessment Phase [ Time Frame: Baseline and Weeks 17-27 ] [ Designated as safety issue: No ]
    Proportion of participants with ≥ 30% reduction from baseline in mean intact parathyroid hormone (iPTH) during the assessment phase.

  • Percent Change from Baseline for Calcium During the Assessment Phase [ Time Frame: Baseline to weeks 17-27 ] [ Designated as safety issue: No ]
    Percent Change from Baseline for Calcium (Ca) During the Assessment Phase

  • Percent Change from Baseline for Phosphorus During the Assessment Phase [ Time Frame: Baseline to weeks 17-27 ] [ Designated as safety issue: No ]
    Percent change from baseline for Phosphorus (P) during the assessment phase

  • Percent Change from Baseline for Ca x P During the Assessment Phase [ Time Frame: Baseline to weeks 17-27 ] [ Designated as safety issue: No ]
    Percent change from baseline for calcium x phosphorus (Ca x P) during the assessment phase

  • Percent Change from Baseline for iPTH During the Assessment Phase [ Time Frame: Baseline to weeks 17-27 ] [ Designated as safety issue: No ]
    Percent change from baseline for intact parathyroid hormone (iPTH) during the assessment phase

  • Proportion of Participants who Attained the K/DOQI Target Range for Ca x P During the Assessment Phase. [ Time Frame: Weeks 17 - 27 ] [ Designated as safety issue: No ]
    Proportion of participants who attained the K/DOQI target range for calcium x phosphorus (Ca x P) during the assessment phase.

  • Proportion of Participants who Attained the K/DOQI Target Range for Ca During the Assessment Phase [ Time Frame: Weeks 17-27 ] [ Designated as safety issue: No ]
    Proportion of participants who attained the K/DOQI target range for calcium (Ca) during the assessment phase.

  • Proportion of Participants who Attained the K/DOQI Target Range for iPTH During the Assessment Phase [ Time Frame: Weeks 17-27 ] [ Designated as safety issue: No ]
    Proportion of participants who attained the K/DOQI target range for intact parathyroid hormone (iPTH) during the assessment phase.

  • Proportion of Participants who Attained the K/DOQI Target Range for P During the Assessment Phase. [ Time Frame: Weeks 17-27 ] [ Designated as safety issue: No ]
    Proportion of participants who attained the K/DOQI target range for phosphorus (P) during the assessment phase.

  • Absolute Change from Baseline for iPTH During the Assessment Phase [ Time Frame: Baseline to weeks 17-27 ] [ Designated as safety issue: No ]
    Absolute change from baseline for intact parathyroid hormone (iPTH) during the assessment phase.

  • Absolute Change from Baseline for Ca During the Assessment Phase [ Time Frame: Baseline to weeks 17-27 ] [ Designated as safety issue: No ]
    Absolute change from baseline for calcium (Ca) during the assessment phase

  • Absolute Change from Baseline for Ca x P During the Assessment Phase [ Time Frame: Baseline to weeks 17-27 ] [ Designated as safety issue: No ]
    Absolute change from baseline for calcium x phosphorus (Ca x P) during the assessment phase.


Enrollment: 170
Study Start Date: August 2005
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cinacalcet and low-dose Vitamin D
Cinacalcet and low-dose IV Vitamin D
Drug: Sensipar®
Cinacalcet hydrochloride
Other Name: Cinacalcet hydrochloride, Cinacalcet HCL, Cinacalcet
Drug: Vitamin D
Vitamin D administered IV
Other Name: paricalcitol, doxercalciferol
Active Comparator: Vitamin D alone
Escalating doses of IV Vitamin D alone
Drug: Vitamin D
Vitamin D administered IV
Other Name: paricalcitol, doxercalciferol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 8.4 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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00135304

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00135304     History of Changes
Other Study ID Numbers: 20050102
Study First Received: August 24, 2005
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Amgen:
Vitamin D
Sensipar®
Cinacalcet HCl
Chronic Kidney Disease

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Vitamin D
Ergocalciferols
Vitamins
1 alpha-hydroxyergocalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014