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 range18 Years

SexALL

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):
✓. Scheduled to receive etelcalcetide for the treatment of HPT per standard of care.
✓. If receiving vitamin D sterols, patient must have had no more than a maximum dose change of 50% within the 4 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable doses for the duration of the study, except for adjustments allowed per protocol\*.

Exclusion criteria

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 range18 Years

SexALL

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):
✓. Scheduled to receive etelcalcetide for the treatment of HPT per standard of care.
✓. If receiving vitamin D sterols, patient must have had no more than a maximum dose change of 50% within the 4 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable doses for the duration of the study, except for adjustments allowed per protocol\*.

Exclusion criteria

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