Trial · NCT05735015
PTH-independent Effects of Encaleret
NCT05735015, Phase 2, Completed, National Institute of Dental and Craniofacial Research (NIDCR); results first posted 2026-03-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PTH-independent Effects of Encaleret. Trials, record NCT05735015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05735015
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PTH-independent Effects of Encaleret
- NCT number
- NCT05735015
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Conditions
- Post-Surgical Hypoparathyroidism
- Interventions
- encaleret
- First posted
- 2023-02-21
- Last updated
- 2026-03-11
- Results first posted
- 2026-03-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Fractional Excretion of Calcium (FECa) | Last measurement (12 hours after last dose of encaleret), baseline (24 hours before first dose of encaleret) | The percentage change in Fractional Excretion of Calcium (FECa) from baseline (24 hours before first dose of encaleret) to the last measurement while on encaleret (12 hours after last dose of encaleret). FECa is calculated using fasting blood levels and spot urine collection of calcium and creatinine. Percent change = (last measurement - baseline)/baseline x 100. |
| Secondary | Proportion of Participants With Concomitant Normal Blood and Urine Calcium | Day 1-5 while on treatment | Proportion of participants who achieve a concomitant normal or elevated fasting blood calcium (albumin-corrected calcium\>8.5 mg/dL) and a normal 24-hour urinary calcium level (\<250 mg/24 hours for women, \<300 mg/24 hours for men) on encaleret at any point between day 1 and day 5 while on treatment. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Fractional Excretion of Calcium (FECa) | Last measurement (12 hours after last dose of encaleret), baseline (24 hours before first dose of encaleret) | Modified intent to treat population | percentage of change | MEAN |
| SECONDARY | Proportion of Participants With Concomitant Normal Blood and Urine Calcium | Day 1-5 while on treatment | Modified intent to treat population | Proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Fractional Excretion of Calcium (FECa) | Participants With Permanent Hypoparathyroidism | -39 | Standard Deviation 29 | percentage of change | |
| Proportion of Participants With Concomitant Normal Blood and Urine Calcium | Participants With Permanent Hypoparathyroidism | 0.9 | 95% Confidence Interval 0.55 to 1.0 | Proportion of participants |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With Permanent Hypoparathyroidism | 10 | |
| Overall Study | Encaleret for 2 Days | Participants With Permanent Hypoparathyroidism | 3 | |
| Overall Study | Encaleret for 5 Days | Participants With Permanent Hypoparathyroidism | 7 | |
| Overall Study | COMPLETED | Participants With Permanent Hypoparathyroidism | 10 | |
| Overall Study | NOT COMPLETED | Participants With Permanent Hypoparathyroidism | 0 |
Source ClinicalTrials.gov
Adverse events17
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 | Hypothyroidism | Endocrine disorders | Participants With Permanent Hypoparathyroidism | 1 | 10 | |
| other | Conjunctivitis | Eye disorders | Participants With Permanent Hypoparathyroidism | 1 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | Participants With Permanent Hypoparathyroidism | 1 | 10 | |
| other | Inguinal hernia | Gastrointestinal disorders | Participants With Permanent Hypoparathyroidism | 1 | 10 | |
| other | Nausea | Gastrointestinal disorders | Participants With Permanent Hypoparathyroidism | 2 | 10 | |
| other | Fatigue | General disorders | Participants With Permanent Hypoparathyroidism | 2 | 10 | |
| other | Pneumonia | Infections and infestations | Participants With Permanent Hypoparathyroidism | 1 | 10 | |
| other | Blood creatine phosphokinase increased | Investigations | Participants With Permanent Hypoparathyroidism | 1 | 10 | |
| other | Hypercalcaemia | Metabolism and nutrition disorders | Participants With Permanent Hypoparathyroidism | 1 | 10 | |
| other | Hypocalcaemia | Metabolism and nutrition disorders | Participants With Permanent Hypoparathyroidism | 8 | 10 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With Permanent Hypoparathyroidism | 0 | 10 |
| Total, other adverse events | Participants With Permanent Hypoparathyroidism | 10 | 10 |
| Total, serious adverse events | Participants With Permanent Hypoparathyroidism | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31063613 | BACKGROUND |
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/NCT05735015
GET https://conductscience.org/api/trials/v1/NCT05735015/registered