Back to resultsEtelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Etelcalcetide
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Clinical Trial, Phase 2, Renal Dialysis, Secondary Hyperparathyroidism, Chronic kidney disease-mineral and bone disorder, Parathyroid hormone
Eligibility Criteria
Inclusion Criteria:
- Subjects provides written informed consent
- 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 or symptomatic ventricular dysrhythmias
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etelcalcetide
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Secondary Outcome Measures
Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period
The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period
The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Percent Change From Baseline in Corrected Calcium During the Efficacy Period
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Percent Change From Baseline in Phosphorus During the Efficacy Period
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01414114
Brief Title
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
Official Title
A Single-arm, Open-label, Multicenter, Dose Titration Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects With Chronic Kidney Disease-Mineral and Bone Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 5, 2011 (undefined)
Primary Completion Date
May 21, 2012 (Actual)
Study Completion Date
May 21, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KAI Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
Clinical Trial, Phase 2, Renal Dialysis, Secondary Hyperparathyroidism, Chronic kidney disease-mineral and bone disorder, Parathyroid hormone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etelcalcetide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Etelcalcetide
Other Intervention Name(s)
KAI-4169, AMG 416, Parsabiv™
Intervention Description
Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period
Description
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Time Frame
Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Secondary Outcome Measure Information:
Title
Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period
Description
The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Time Frame
Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Title
Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period
Description
The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Time Frame
The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Title
Percent Change From Baseline in Corrected Calcium During the Efficacy Period
Description
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Time Frame
Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Title
Percent Change From Baseline in Phosphorus During the Efficacy Period
Description
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Time Frame
Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects provides written informed consent
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 or symptomatic ventricular dysrhythmias
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Bell, MD
Organizational Affiliation
KAI Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
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