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ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism
This study has been completed.
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00135304
  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®
Phase IV

Drug Information available for: Vitamin D Ergocalciferol Cinacalcet Cinacalcet hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • The proportion of subjects in each treatment group simultaneously 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 mg²/dl²) during the assessment phase

Secondary Outcome Measures:
  • Proportion of subjects attaining NKF-K/DOQI targets for biPTH (80-160 pg/ml), Ca (8.4-9.5 mg/dl), P (3.5-5.5 mg/dl) or Ca x P (less than 55 mg²/dl²) during the assessment phase
  • Absolute and percent change from baseline for biPTH, Ca, P and Ca x P during the assessment phase
  • Proportion of subjects with greater than 30% reduction in biPTH during the assessment phase

Estimated Enrollment: 170
Study Start Date: August 2005
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135304

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

AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20050102
Study First Received: August 24, 2005
Last Updated: December 20, 2007
ClinicalTrials.gov Identifier: NCT00135304  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Parathyroid Diseases
Hyperparathyroidism, Secondary
Vitamin D
Hyperparathyroidism
Renal Insufficiency, Chronic
Ergocalciferols
Kidney Failure, Chronic
Neoplasm Metastasis
Endocrine System Diseases
Endocrinopathy
Kidney Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009