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Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01414114
First received: August 9, 2011
Last updated: February 27, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention Phase
Secondary Hyperparathyroidism
Drug: Etelcalcetide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:
  • Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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.


Enrollment: 37
Study Start Date: December 5, 2011
Study Completion Date: May 21, 2012
Primary Completion Date: May 21, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Etelcalcetide
Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.
Other Names:
  • KAI-4169
  • AMG 416
  • Parsabiv™

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414114

Sponsors and Collaborators
KAI Pharmaceuticals
Investigators
Study Director: Gregory Bell, MD KAI Pharmaceuticals
  More Information

Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01414114     History of Changes
Other Study ID Numbers: KAI-4169-005
20120331 ( Other Identifier: Amgen, Inc )
Study First Received: August 9, 2011
Results First Received: February 27, 2017
Last Updated: February 27, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KAI Pharmaceuticals:
Clinical Trial, Phase 2
Renal Dialysis
Secondary Hyperparathyroidism
Chronic kidney disease-mineral and bone disorder
Parathyroid hormone

Additional relevant MeSH terms:
Neoplasm Metastasis
Renal Insufficiency, Chronic
Kidney Diseases
Hyperparathyroidism
Hyperparathyroidism, Secondary
Bone Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 25, 2017