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START: Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00132431
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : February 13, 2009
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Brief Summary:
The purpose of this research is to study the effects and safety of Sensipar approved by the Food and Drug Administration (FDA) in patients with kidney failure who are being treated with dialysis and have uncontrolled secondary hyperparathyroidism (HPT).

Condition or disease Intervention/treatment Phase
Kidney Disease Secondary Hyperparathyroidism Chronic Kidney Disease Drug: Sensipar Phase 4

Detailed Description:
The purposes of this study are: - To assess the effectiveness of a treatment algorithm that includes Sensipar on bio-intact parathyroid hormone (biPTH), adjusted serum calcium (Ca), serum phosphorus (P), and calcium-phosphorus product (Ca x P) levels in the management of SHPT in CKD subjects on dialysis by determining achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Guideline targets. - To assess the use of vitamin D sterols and phosphate binders when Sensipar is incorporated in the treatment of SHPT. - To assess the safety and tolerability of Sensipar.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism
Study Start Date : July 2004
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Primary Outcome Measures :
  1. Proportion of subjects with a mean bio-intact parathyroid hormone (biPTH) >/= 80 pg/mL and </= 160 pg/mL (comparable to K/DOQI Guideline target range for intact parathyroid hormone [iPTH] of >/= 150 pg/mL and </= 300 pg/mL) during the assessment phase

Secondary Outcome Measures :
  1. Proportion of subjects with mean calcium-phosphorus product (Ca x P) < 55 mg²/dL² during the assessment phase

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Inclusion Criteria: - Subjects with chronic kidney disease who have received dialysis for at least one month before the first dose of study medication and are clinically stable. - Adults at least 18 years of age who have given written informed consent. - Out of target PTH values, defined as the most recent historical measurement of biPTH > 160 pg/mL within 3 months prior to informed consent signature. - Serum calcium >/= 8.4 mg/dL within one month prior to informed consent signature. Exclusion Criteria: - Unstable medical condition, defined as having been hospitalized within 30 days before Day 1, or otherwise unstable in the judgement of the investigator. Hospitalization solely for dialysis vascular access revision does not qualify as an unstable medical condition. - Parathyroidectomy in the 3 months before Day 1. - 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 trial of investigational drug or device (except experimental dialysis machines) within 30 days of enrollment into the study. Any investigational procedures. - Females of child-bearing potential who are pregnant (e.g., positive serum pregnancy test) or are breast feeding. Females of child bearing potential who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study. - Hypersensitivity to Sensipar or any of its components. - Previously participated in this or any other Sensipar study, or received/is receiving Sensipar as a commercially available product. - Disorder that would compromise the ability of the subject to give written informed consent and/or to comply with study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00132431

Sponsors and Collaborators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00132431    
Other Study ID Numbers: 20040123
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: February 2009
Keywords provided by Amgen:
secondary hyperparathyroidism
chronic kidney disease
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists