Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
NCT ID: NCT01414114
Last Updated: 2017-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2011-12-05
2012-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Etelcalcetide
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
Etelcalcetide
Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.
Interventions
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Etelcalcetide
Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
* Hemoglobin ≥ 8.5 g/dL
* Serum transaminases (alanine transaminase \[ALT\], aspartate transaminase \[AST\]) less than 2.5 times the upper limit of normal
* Adequate hemodialysis three times per week
Exclusion Criteria
* History of angina pectoris or congestive heart failure
* History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
* History of or treatment for seizure disorder within the last 12 months
* Postdialysis systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 90 mmHg
* Serum magnesium below the lower limit of normal at screening
18 Years
ALL
No
Sponsors
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KAI Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Bell, MD
Role: STUDY_DIRECTOR
KAI Pharmaceuticals
Other Identifiers
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20120331
Identifier Type: OTHER
Identifier Source: secondary_id
KAI-4169-005
Identifier Type: -
Identifier Source: org_study_id
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