End Stage Renal DiseasePhase 2NCT03795558
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
A Phase 2 study testing Etelcalcetide in people with End Stage Renal Disease, run by Prim. Priv. Doz. Dr. Daniel Cejka at 1 site in Austria.
Trial summary
This is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Etelcalcetide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2019to 1 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prevalent patients (≥ 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF)
- Secondary hyperparathyroidism defined as PTH levels > 9x ULN according to current KDIGO guidelines if therapy-naïve, or patients already treated with calcium receptor sensitizers with PTH > 2x ULN
- Albumin corrected calcium ≥ 2,08 mmol/l
- Calcium concentrations of dialysate stable for at least 2 weeks prior to screening
Who cannot join
- Currently receiving treatment in another investigational device or drug study or participation in non-interventional studies
- Current treatment with etelcalcetide (Parsabiv©) or treatment with etelcalcetide within 3 months prior to study inclusion
- Patient has known sensitivity to any of the products or components of Parsabiv©
- Patient has received a parathyroidectomy
- Parathyroidectomy planned or expected during the study period
- Elective kidney transplant scheduled during the study period
Show all 12Show fewer
- Therapy with bisphosphonates within the past 12 months
- Therapy with denosumab within the past 6 months
- Antacids containing aluminum, calcium, magnesium or bicarbonate
- Patient has a history of symptomatic ventricular arrhythmias or Torsades de Pointes
- Patient has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
- Pregnant or nursing (lactating) women
Trial locations and contacts
1 site in 1 country.
Austria1 site
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020
About this study
This is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism.
Read the detailed description
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
- Conditions
- End Stage Renal Disease
- Being tested
- Etelcalcetide
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtelcalcetideDrug
Also called Parsabiv
Up-Titration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Etelcalcetide |
| 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 Receives: Drug: Etelcalcetide |
| 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 Receives: Drug: Etelcalcetide |
| 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 Receives: Drug: Etelcalcetide |
| 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 Receives: Drug: Etelcalcetide |
| 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 Receives: Drug: Etelcalcetide |
What is being measured
The primary outcome is the main question the study is designed to answer.
T50-Laboratory Test for measuring calcification
The changes in T50 values between the different study phases will be evaluated as the primary outcome.
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start1 May 2019
- Primary completion21 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prim. Priv. Doz. Dr. Daniel Cejka
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor-investigator, Prim. Priv. Doz. Dr. Daniel Cejka, Elisabethinen Hospital
- Investigators
- Daniel Cejka, Md, Principal investigator, Head of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795558
- Sponsor's protocol ID
- Etelcalcetide-T50-CKD5D
- Status last verified
- Mar 2022
- First submitted
- 18 Sep 2018
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
- ClinicalTrials.gov ID
- NCT03795558
- Acronym / sponsor ID
- Etelcalcetide-T50-CKD5D
- Conditions
- End Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Prim. Priv. Doz. Dr. Daniel CejkaUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 1 May 2019 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Etelcalcetide 2.5 mg | Experimental | Drug: EtelcalcetideEtelcalcetide, 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 | Drug: EtelcalcetideEtelcalcetide, 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 | Drug: EtelcalcetideEtelcalcetide, 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 | Drug: EtelcalcetideEtelcalcetide, 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 | Drug: EtelcalcetideEtelcalcetide, 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 15 mg | Experimental | Drug: EtelcalcetideEtelcalcetide, 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prevalent patients (≥ 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF)
- Secondary hyperparathyroidism defined as PTH levels > 9x ULN according to current KDIGO guidelines if therapy-naïve, or patients already treated with calcium receptor sensitizers with PTH > 2x ULN
- Albumin corrected calcium ≥ 2,08 mmol/l
- Calcium concentrations of dialysate stable for at least 2 weeks prior to screening
Key exclusion criteria (12 listed)
- Currently receiving treatment in another investigational device or drug study or participation in non-interventional studies
- Current treatment with etelcalcetide (Parsabiv©) or treatment with etelcalcetide within 3 months prior to study inclusion
- Patient has known sensitivity to any of the products or components of Parsabiv©
- Patient has received a parathyroidectomy
- Parathyroidectomy planned or expected during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtelcalcetideAlso: ParsabivUp-Titration | Drug | Etelcalcetide 10 mg, Etelcalcetide 12,5 mg, Etelcalcetide 15 mg, Etelcalcetide 2.5 mg, Etelcalcetide 5 mg, Etelcalcetide 7,5 mg |
Primary outcome
T50-Laboratory Test for measuring calcification
Time frame: 32 weeks
The changes in T50 values between the different study phases will be evaluated as the primary outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Cejka, Md principal investigator
Head of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etelcalcetide in people with End Stage Renal Disease, run by Prim. Priv. Doz. Dr. Daniel Cejka at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T50-Laboratory Test for measuring calcification (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.