CompletedPhase 2

The Effect of Etelcalcetide on CKD-MBD

United States22 participantsStarted 2018-09-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient has provided informed consent.
. Patient is 18 years of age or older.
. Patient must be receiving maintenance hemodialysis for at least 3 months, with adequate hemodialysis with a delivered Kt/V 1.2 or urea reduction ratio (URR) 65% within 4 weeks prior to screening laboratory assessments.
. Dialysate calcium concentration must be stable for at least 4 weeks prior to screening laboratory assessments.
. Patient must have severe HPT as defined by two laboratory screening pre-dialysis serum PTH values \>9-times ULN for the PTH assay, measured on two consecutive monthly lab checks prior to entering the study.
. The patient has an uncontrolled PTH defined by KDIGO as a PTH greater than 9 times the upper limit of normal of the assay (720 pg/mL for Rogosin):

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change in PTH Levels

Timeframe: Baseline and 9 months

Change in Bone Mineral Density (BMD) of the Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)

Timeframe: Baseline and 9 months

Propensity as Measured by T50

Timeframe: 9 months

Percent Change in Mean Hardness

Timeframe: Baseline and 9 months

Trial details

NCT IDNCT03960437

SponsorThomas Nickolas, MD MS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-19

Results submitted2022-04-08

View on ClinicalTrials.gov More Chronic Kidney Disease Mineral and Bone Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient has provided informed consent.
. Patient is 18 years of age or older.
. Patient must be receiving maintenance hemodialysis for at least 3 months, with adequate hemodialysis with a delivered Kt/V 1.2 or urea reduction ratio (URR) 65% within 4 weeks prior to screening laboratory assessments.
. Dialysate calcium concentration must be stable for at least 4 weeks prior to screening laboratory assessments.
. Patient must have severe HPT as defined by two laboratory screening pre-dialysis serum PTH values \>9-times ULN for the PTH assay, measured on two consecutive monthly lab checks prior to entering the study.
. The patient has an uncontrolled PTH defined by KDIGO as a PTH greater than 9 times the upper limit of normal of the assay (720 pg/mL for Rogosin):

What they're measuring

Percent Change in PTH Levels

Timeframe: Baseline and 9 months

Change in Bone Mineral Density (BMD) of the Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)

Timeframe: Baseline and 9 months

Propensity as Measured by T50

Timeframe: 9 months

Percent Change in Mean Hardness

Timeframe: Baseline and 9 months

The Effect of Etelcalcetide on CKD-MBD

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

The Effect of Etelcalcetide on CKD-MBD

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria