Trial · NCT03960437
The Effect of Etelcalcetide on CKD-MBD
NCT03960437, Phase 2, Completed, Thomas Nickolas, MD MS; results first posted 2023-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Etelcalcetide on CKD-MBD. Trials, record NCT03960437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03960437
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Etelcalcetide on CKD-MBD
- NCT number
- NCT03960437
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Thomas Nickolas, MD MS
- Conditions
- Chronic Kidney Disease Mineral and Bone Disorder, Renal Osteodystrophy, Vascular Calcification, Hyperparathyroidism; Secondary, Renal
- Interventions
- Etelcalcetide
- First posted
- 2019-05-23
- Last updated
- 2023-09-21
- Results first posted
- 2023-09-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in PTH Levels | Baseline and 9 months | Mean percent change in parathyroid hormone (PTH) levels will be calculated. |
| Primary | Change in Bone Mineral Density (BMD) of the Femoral Neck by Dual-energy X-ray Absorptiometry (DXA) | Baseline and 9 months | 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. |
| Primary | Propensity as Measured by T50 | 9 months | 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. |
| Primary | Percent Change in Mean Hardness | Baseline and 9 months | Hardness will be measured by Ramen nano-indentation and mineralization measured by histomorphometry obtained (in GPa). |
| Secondary | Change in Bone Mineral Density (BMD) of the Spine by DXA | Baseline and 9 months | 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. |
| Secondary | Change in Bone Mineral Density (BMD) of Total Hip by DXA | Baseline and 9 months | 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. |
| Secondary | Change in Bone Formation Rate | Baseline and 9 months | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in PTH Levels | Baseline and 9 months | Only includes participants who completed the study | percentage of change in PTH levels | MEAN |
| PRIMARY | Change in Bone Mineral Density (BMD) of the Femoral Neck by Dual-energy X-ray Absorptiometry (DXA) | Baseline and 9 months | Only includes participants who completed the study. | Z-score | MEAN |
| PRIMARY | Propensity as Measured by T50 | 9 months | No data, as measured by T50, was collected. Therefore there is no data that can be reported. | ||
| PRIMARY | Percent Change in Mean Hardness | Baseline and 9 months | Only includes participants who completed the histomorphometry. | percent of change in hardness | MEAN |
| SECONDARY | Change in Bone Mineral Density (BMD) of the Spine by DXA | Baseline and 9 months | Only includes participants who completed the study. | Z-score | MEAN |
| SECONDARY | Change in Bone Mineral Density (BMD) of Total Hip by DXA | Baseline and 9 months | Only includes participants who completed the study. | Z-score | MEAN |
| SECONDARY | Change in Bone Formation Rate | Baseline and 9 months | Only includes participants who completed the bone biopsy substudy. | percentage of change | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in PTH Levels | Study Participant | Baseline | 0 | Standard Error 0 | percentage of change in PTH levels |
| Percent Change in PTH Levels | Study Participant | 6 months | -54.14 | Standard Error 11.50 | percentage of change in PTH levels |
| Percent Change in PTH Levels | Study Participant | 9 months | -64.04 | Standard Error 8.62 | percentage of change in PTH levels |
| Change in Bone Mineral Density (BMD) of the Femoral Neck by Dual-energy X-ray Absorptiometry (DXA) | Study Participant | 0.43 | Standard Error 0.1 | Z-score | |
| Percent Change in Mean Hardness | Study Participant | 2.68 | Standard Error 8.92 | percent of change in hardness | |
| Change in Bone Mineral Density (BMD) of the Spine by DXA | Study Participant | 0.27 | Standard Error 0.1 | Z-score | |
| Change in Bone Mineral Density (BMD) of Total Hip by DXA | Study Participant | 0.12 | Standard Error 0.07 | Z-score | |
| Change in Bone Formation Rate | Study Participant | -84 | Standard Error 17 | percentage of change |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study Participant | 22 | |
| Overall Study | COMPLETED | Study Participant | 13 | |
| Overall Study | NOT COMPLETED | Study Participant | 9 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cold Sores | Infections and infestations | Study Participant | 1 | 22 | 1 |
| other | Gastrointestinal Disorder | Gastrointestinal disorders | Study Participant | 1 | 22 | 1 |
| serious | COVID-19 infection | Infections and infestations | Study Participant | 1 | 22 | 1 |
| serious | Cardiac Event | Cardiac disorders | Study Participant | 1 | 22 | 1 |
| serious | Vertigo/Dizziness | General disorders | Study Participant | 1 | 22 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study Participant | 2 | 22 |
| Total, other adverse events | Study Participant | 2 | 22 |
| Total, serious adverse events | Study Participant | 3 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37574661 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03960437
GET https://conductscience.org/api/trials/v1/NCT03960437/registered