The effect of the drug etelcalcetide on heart muscle enlargement in hemodialysis patients - a randomized, controlled trial

Phase 1

• Conditions: Secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis therapy.; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2017-000222-35-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-12
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• = 18 years of age
• Treatment with maintenance hemodialysis 3 times a week for = 3 months and =3
years
• sekundary hyperparathyroidism defined by
o Parathyroid hormone levels obtained from the central laboratory of =300 pg/mL and no prior treatment with a calcimimetic drug, or
o patients under treatment with cinacalcet who will be eligible following a washout phase of 4 weeks
• serum calcium levels obtained from the central laboratory of = 2.08 mmol/L
• Signs of left ventricular hypertrophy (increased myocardial thickness in the left ventricle, increased intraventricular septum thickness) +/- signs of cardiac fibrosis in cardiac imaging
(Echocardiography)
• State of optimal fluid composition i.e. reaching the individual dry weight as measured
with the help of a Body Composition Monitor. Pulmonary edema will be excluded with the help of lung ultrasound (lung comet tails).
• No substantial dose change of calcium supplements, phosphate binders, dialysate calcium 4 weeks before screening

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

• Unstable medical condition based on medical history, physical examination, and routine laboratory tests, or judged unstable in the investigator’s opinion
• Significantly impaired left ventricular systolic function or significant, hemodynamically effective heart valve defects
• History of any illness, which in the investigator’s opinion, might confound the results of the study or pose additional risk
• Anticipated parathyreoidectomy within 6 months after randomization
• Scheduled date for kidney transplant from a living donor
• Uncontrolled hyperphosphatemia
• Subject is currently enrolled in or has not yet completed at least 30 days since ending
other investigational device or drug trial(s), or subject is receiving other
investigational agent(s)
• Subject has known sensitivity or intolerance to any of the products to be
administered for the purpose of this study
• Subject has any kind of disorder that compromises the ability of the subject to give
written informed consent and/or to comply with the study procedures
• Subject is pregnant, or is of child-bearing potential and not using adequate contraceptive precautions
• Contraindications for MRI (implanted MR-Unsafe – objects that are significantly
ferromagnetic and pose a clear and direct threat to persons and equipment within
the magnet room)
• Overhydration as measured in BCM or visualized in lung ultrasound

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified