A Phase 2 interventional study of Etelcalcetide in Chronic Kidney Disease Mineral and Bone Disorder, Renal Osteodystrophy and Vascular Calcification, sponsored by Thomas Nickolas, MD MS. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Thomas Nickolas, MD MS · Phase 2, Interventional, and Treatment
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.
Chronic kidney disease - mineral and bone disease (CKD-MBD) is a disorder of bone and mineral metabolism in patients with CKD. When kidney function is poor, levels of vitamin D, phosphate and parathyroid hormone become abnormal and patients are at risk for bone disease and fractures (renal osteodystrophy) and the deposition of calcium in blood vessels and muscles. CKD-MBD increases the risk of fractures, heart attacks, strokes, and death. Treatment of CKD-MBD is focused on lowering levels of parathyroid hormone (PTH) by giving vitamin D and lowering levels of phosphorous by giving phosphate binders. In patients with end stage kidney disease (ESKD), target levels of PTH recommended by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines are in the range of 2-9 times the upper limit of normal (ULN) for the PTH assay. In many cases, in patients with long-standing ESKD, the parathyroid gland may no longer respond to treatment with vitamin D and phosphate lowering. In these cases, treatment with a calcimimetic, a medicine that increases the sensitivity of the parathyroid gland to serum levels of calcium, can restore PTH levels to goal.
73 studies on the registry are indexed under Chronic Kidney Disease-Mineral and Bone Disorder; 20 are open to participants now.
This study's enrollment of 22 is below the median of 54 across 34 interventional studies indexed under Chronic Kidney Disease-Mineral and Bone Disorder.
Browse Chronic Kidney Disease-Mineral and Bone Disorder studies →Thomas Nickolas, MD MS is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For All Aims:
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):
AND one of the following:
For Aim 1:
Exclusion Criteria:
For All Aims:
For Aim 1 (Bone ):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Every study participant will receive etelcalcetide prescribed by their treating physician for the duration of the study.
Drug: Etelcalcetide
Administered intravenously at the end of each dialysis session. Dosing ranges from 5 mg to 15 mg set by the patient's physician.
Also known as: Parsabiv
Percent Change in PTH Levels
Mean percent change in parathyroid hormone (PTH) levels will be calculated.
Time frame: Baseline and 9 months
Change in Bone Mineral Density (BMD) of the Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)
To test if 9-months of treatment with etelcalcetide changes femoral neck areal BMD, a change in age and sex adjusted Z-Score will be calculated from baseline to 9 months. A Z-Score of zero represent the population mean and higher Z-Scores indicate a better outcome.
Time frame: Baseline and 9 months
Propensity as Measured by T50
The propensity to calcify soft tissues will be measured by T50 for 9 months of treatment. T50 is a novel serum-based marker that assesses the propensity of calcification in serum. Shorter T50 indicates greater propensity to calcify.
Time frame: 9 months
Percent Change in Mean Hardness
Hardness will be measured by Ramen nano-indentation and mineralization measured by histomorphometry obtained (in GPa).
Time frame: Baseline and 9 months
Change in Bone Mineral Density (BMD) of the Spine by DXA
To test if 9-months of treatment with etelcalcetide improves spine BMD, a change in age and sex adjusted Z-Score will be calculated from baseline to 9 months. A Z-Score of zero represent the population mean and higher Z-Scores indicate a better outcome.
Time frame: Baseline and 9 months
Change in Bone Mineral Density (BMD) of Total Hip by DXA
To test if 9-months of treatment with etelcalcetide improves total hip BMD, the change in age and sex adjusted Z-Score will be calculated from baseline to 9 months. A Z-Score of zero represent the population mean and higher Z-Scores indicate a better outcome.
Time frame: Baseline and 9 months
Change in Bone Formation Rate
A quadruple label method will be used to assess effects of etelcalcetide on the bone formation rate. A tetracycline double label will be used pre-etelcalcetide and a declomycin double label will be used post-etelcalcetide in a protocol that administers label 3-days on, 12-days interlude, 3-days on. A single bone biopsy will be performed 1 to 10 days after completion of the second double label. Biopsy cores will be placed into 70% ethanol then serially dehydrated and embedded in methyl methacrylate. Four-micron thick sections will be cut and left unstained for dynamic histomorphometry. A region of interest including all trabecular bone and excluding cortical bone will be analyzed separately for each tetracycline or declomycin label. Standard analysis techniques will be used to measure single, double and no labelled surfaces and distances between the two labels of each fluorescence. Standard calculations of the bone formation rate/bone surface (um3/um2/year) will be made.
Time frame: Baseline and 9 months
| Milestone | Study Participant |
|---|---|
| Started | 22 |
| Completed | 13 |
| Not completed | 9 |
| Withdrew: Removed by pi | 4 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Death | 2 |
Mean percent change in parathyroid hormone (PTH) levels will be calculated.
| percentage of change in PTH levels | Study Participant |
|---|---|
| Baseline | 0 ± 0 |
| 6 months | -54.14 ± 11.50 |
| 9 months | -64.04 ± 8.62 |
To test if 9-months of treatment with etelcalcetide changes femoral neck areal BMD, a change in age and sex adjusted Z-Score will be calculated from baseline to 9 months. A Z-Score of zero represent the population mean and higher Z-Scores indicate a better outcome.
| Z-score | Study Participant |
|---|---|
| Change in Bone Mineral Density (BMD) of the Femoral Neck by Dual-energy X-ray Absorptiometry (DXA) | 0.43 ± 0.1 |
The propensity to calcify soft tissues will be measured by T50 for 9 months of treatment. T50 is a novel serum-based marker that assesses the propensity of calcification in serum. Shorter T50 indicates greater propensity to calcify.
No measurements were reported for this outcome.
Hardness will be measured by Ramen nano-indentation and mineralization measured by histomorphometry obtained (in GPa).
| percent of change in hardness | Study Participant |
|---|---|
| Percent Change in Mean Hardness | 2.68 ± 8.92 |
To test if 9-months of treatment with etelcalcetide improves spine BMD, a change in age and sex adjusted Z-Score will be calculated from baseline to 9 months. A Z-Score of zero represent the population mean and higher Z-Scores indicate a better outcome.
| Z-score | Study Participant |
|---|---|
| Change in Bone Mineral Density (BMD) of the Spine by DXA | 0.27 ± 0.1 |
To test if 9-months of treatment with etelcalcetide improves total hip BMD, the change in age and sex adjusted Z-Score will be calculated from baseline to 9 months. A Z-Score of zero represent the population mean and higher Z-Scores indicate a better outcome.
| Z-score | Study Participant |
|---|---|
| Change in Bone Mineral Density (BMD) of Total Hip by DXA | 0.12 ± 0.07 |
A quadruple label method will be used to assess effects of etelcalcetide on the bone formation rate. A tetracycline double label will be used pre-etelcalcetide and a declomycin double label will be used post-etelcalcetide in a protocol that administers label 3-days on, 12-days interlude, 3-days on. A single bone biopsy will be performed 1 to 10 days after completion of the second double label. Biopsy cores will be placed into 70% ethanol then serially dehydrated and embedded in methyl methacrylate. Four-micron thick sections will be cut and left unstained for dynamic histomorphometry. A region of interest including all trabecular bone and excluding cortical bone will be analyzed separately for each tetracycline or declomycin label. Standard analysis techniques will be used to measure single, double and no labelled surfaces and distances between the two labels of each fluorescence. Standard calculations of the bone formation rate/bone surface (um3/um2/year) will be made.
| percentage of change | Study Participant |
|---|---|
| Change in Bone Formation Rate | -84 ± 17 |
Collected over 9 months after baseline. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Participant | 2/22 (9.1%) | 3/22 (13.6%) | 2/22 (9.1%) |
| Event | Study Participant |
|---|---|
| COVID-19 infectionInfections and infestations | 1/22 |
| Cardiac EventCardiac disorders | 1/22 |
| Vertigo/DizzinessGeneral disorders | 1/22 |
| Event | Study Participant |
|---|---|
| Cold SoresInfections and infestations | 1/22 |
| Gastrointestinal DisorderGastrointestinal disorders | 1/22 |
| Age, Categorical(Participants) | Study Participant |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 5 |
| Sex: Female, Male(Participants) | Study Participant |
|---|---|
| Female | 11 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | Study Participant |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 18 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Study Participant |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 15 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Washout of Cinacalcet Required(Participants) | Study Participant |
|---|---|
| Count of participants | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2018 to primary completion in Nov 2020, 26 months.
Results were first posted in Sep 2023, 2 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Etelcalcetide
Chronic Kidney Disease-Mineral and Bone Disorder →
Thomas Nickolas, MD MS