Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amgen | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism.
Fifteen prevalent and stable hemodialysis patients with secondary hyperparathyroidism eligible for treatment with calcium receptor sensitizers according to current KDIGO will be included.
Study phases will begin and end on the day of the first hemodialysis session of the week.
The run-in phase will last 4 weeks. No calcimimetics will be prescribed during the run-in phase.
The treatment phase starts with a dose of etelcalcetide is 2.5mg thrice weekly. Etelcalcetide dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly.
The wash-out Phase starts after completion of the 15mg thrice-weekly phase or in case a pre-specified safety endpoint is reached, etelcalcetide will be discontinued and patients will be followed for additional 8 weeks to study any potential reversibility of PTH lowering on T50 results.
For the individual patient, the study duration will be 9 months
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etelcalcetide 2.5 mg | Experimental | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly |
|
| Etelcalcetide 5 mg | Experimental | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly |
|
| Etelcalcetide 7,5 mg | Experimental | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly |
|
| Etelcalcetide 10 mg | Experimental | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly |
|
| Etelcalcetide 12,5 mg | Experimental | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etelcalcetide | Drug | Up-Titration |
|
| Measure | Description | Time Frame |
|---|---|---|
| T50-Laboratory Test for measuring calcification | The changes in T50 values between the different study phases will be evaluated as the primary outcome. | 32 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Cejka, Md | Head of Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordensklinikum Linz GmbH Elisabethinen | Linz | Upper Austria | 4020 | Austria |
Not provided
This is a single-center, prospective, dose-escalation, pilot study. Starting dose 2.5 mg thrice weekly dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly.
Not provided
Not provided
Not provided
Not provided
|
| Etelcalcetide 15 mg | Experimental | Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly |
|
|
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C583569 | etelcalcetide hydrochloride |
Not provided
Not provided
Not provided