drugset / Trial / NCT03960437

The Effect of Etelcalcetide on CKD-MBD

NCT03960437

Phase 2 Completed 22 enrolled Thomas Nickolas, MD MS
NaSingle-groupOpen-labelTreatment

Summary

The proposed study will investigate the effects of etelcalcetide on the bone and blood-vessel health in patients with CKD-MBD. The investigators will test if etelcalcetide makes bone and blood-vessels healthier. The study hypotheses are that are that etelcalcetide keeps bones strong and lowers the risk of calcium deposits in blood vessels. In Aim 1, the investigators will test if 9-months of treatment with etelcalcetide improves bone strength in twenty ESKD patients with hyperparathyroidism (HPT) by bone biopsy. In Aim 2, the investigators will test if 9-months of treatment with etelcalcetide decreases serum propensity to calcify blood vessels. The potential significance of this study is to provide first-time data on the ability of etelcalcetide to protect bone and blood-vessel health in patients with ESKD.

Timeline

Start
2018-09-06
Primary completion
2020-11-19
Completion
2020-11-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Etelcalcetide Other / unclassified 5 mg Intravenous
Subject Etelcalcetide Other / unclassified 15 mg Intravenous