Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients

Summary

Background:

Calcimimetic therapy has been shown to reduce systemic FGF23 levels, which themselves are associated with left ventricular hypertrophy (LVH) in chronic kidney disease (CKD).

Methods/design:

This is a randomized multicenter trial in which the effect of etelcalcetide in comparison to alfacalcidol on LVH and cardiac fibrosis in hemodialysis patients with secondary hyperparathyroidism (sHPT) will be investigated.

The investigators will perform a comparative trial testing etelcalcetide vs. alfacalcidol treatment on top of conventional HPT therapy for 12 months. A total of 62 hemodialysis patients with sHPT and LVH will be enrolled in the study. After a washout of all calcimimetic and vitamin D treatment, subjects will be randomized at 1:1 ratio to either etelcalcetide or alfacalcidol. The participants will undergo cardiac imaging consisting of cardiac resonance imaging (cMRI) and strain echocardiography before and at baseline and one year. Etelcalcetide or alfacalcidol will be administered intravenously three times per week following chronic hemodialysis treatment.

The primary end point will be a change in left ventricular mass index (LVMI) measured in g/m2. As secondary end points the changes in left atrial diameter (LAD), cardiac fibrosis, wall motion abnormalities and left ventricular function, changes in serum FGF 23 and soluble Klotho levels as well as changes in proBNP as well as pre- and postdialysis troponin T (TnT) levels will be determined. Additionally a quantitative analysis of the treatment influence on the individual metabolites of the renin-angiotensin-aldosterone system (RAAS) will be performed using mass spectrometry ("RAAS fingerprint").

Conditions

• Secondary Hyperparathyroidism
• Chronic Kidney Disease Requiring Chronic Dialysis
• Left Ventricular Hypertrophy

Interventions

DIAGNOSTIC_TEST

cardiac MRI

non contrast heart MRI at baseline and after 1 year of therapy

DIAGNOSTIC_TEST

echocardiography with strain

echocardiography at baseline and after 1 year of therapy

DIAGNOSTIC_TEST

Laboratory tests

drawing blood from dialysis machine

DIAGNOSTIC_TEST

Body composition monitoring

Measurement with BCM (Fresenius) machine

DIAGNOSTIC_TEST

lung ultrasound

ultrasound

Sponsors & Collaborators

• Amgen

  collaborator INDUSTRY

• Rainer Oberbauer

  lead OTHER

Principal Investigators

• Rainer Oberbauer, Univ.Prof. · Head of the department of Nephrology of the MUVienna

• Matthias Lorenz, Priv.Doz. · Head of the Dialysis center (WDZ)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-01

Primary Completion

2019-12-20

Completion

2019-12-20

Countries

• Austria

Study Locations