Clinical trial NCT01414114: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Keywords: Clinical Trial, Phase 2
Renal Dialysis
Secondary Hyperparathyroidism
Chronic kidney disease-mineral and bone disorder
Parathyroid hormone
Lead sponsor: KAI Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period
timeFrame: 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 outcomes:
measure: Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period
timeFrame: 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)
measure: Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period
timeFrame: 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)
measure: Percent Change From Baseline in Corrected Calcium During the Efficacy Period
timeFrame: 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)
measure: Percent Change From Baseline in Phosphorus During the Efficacy Period
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: KAI Pharmaceuticals
name: Gregory Bell, MD
role: STUDY_DIRECTOR
References: