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Completed

NCT Number: NCT01414114

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

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).

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Key information

Conditions

Secondary Hyperparathyroidism Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Chronic Disease Chronic Kidney Disease-Mineral and Bone Disorder Deficiency Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rickets Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etelcalcetide

Drug

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™

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

KAI Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 11, 2011
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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