Trial · NCT05239221
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Emergent Adverse Events (TEAEs) | Up to 2 weeks in Part A and Part B, and up to 3 months in Part C | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Observed Maximum Concentration (Cmax) - Part A | 24 hours | pg/mL | MEAN | |
| SECONDARY | Observed Maximum Concentration (Cmax) - Part B | Day 1, Day 14 | Data not collected for a few subjects (missing data or site error) | pg/mL | MEAN |
| SECONDARY | Observed Maximum Concentration (Cmax) - Part C | Day 1, Day 14, Day 28, Day 84 | One (1) subject dropped out in Cohort 2 prior to the extension phase and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). In addition, data not collected for a few subjects (missing data or site error). PK data was not collected in Cohort 1 on Day 84 per the protocol at the time. The protocol was updated following completion of Cohort 1 to collect PK information in Cohort 2 on Day 84. | pg/mL | MEAN |
| SECONDARY | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part A | 24 hours | pg*h/mL | MEAN | |
| SECONDARY | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part B | Day 1, Day 14 | Data not collected for a few subjects (missing data or site error). | pg*h/mL | MEAN |
| SECONDARY | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part C | Day 1, Day 14, Day 28, Day 84 | One (1) subject dropped out in Cohort 2 prior to the extension phase and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). In addition, data not collected for a few subjects (missing data or site error). Pharmacokinetic (PK) data was not collected in Cohort 1 on Day 84 per the protocol at the time. The protocol was updated following completion of Cohort 1 to collect PK information in Cohort 2 on Day 84. | pg*h/mL | MEAN |
| SECONDARY | Calcium Corrected for Albumin - Part A | 24 hours | mg/dL | MEAN | |
| SECONDARY | Calcium Corrected for Albumin - Part B | 24 hours, Day 14 | One (1) subject in Cohort B4 discontinued from the study. | mg/dL | MEAN |
| SECONDARY | Calcium Corrected for Albumin - Part C | Day 1, Day 14, Day 28 and Day 84 | One (1) subject dropped out in Cohort 2 prior to the extension phase. In addition to this subject, two (2) subjects from Cohort 1 and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). In addition, data not collected for a few subjects (missing data or site error). | mg/dL | MEAN |
| SECONDARY | Serum Phosphate - Part A | 24 hours | mg/dL | MEAN | |
| SECONDARY | Serum Phosphate - Part B | Day 1, Day 14 | One (1) subject in Cohort B4 discontinued from the study. | mg/dL | MEAN |
| SECONDARY | Serum Phosphate - Part C | Day 1 (H0), Day 14 (H2), Day 28 (H2) and Day 84 (H2) | One (1) subject dropped out in Cohort 2 prior to the extension phase. In addition to this subject, two (2) subjects from Cohort 1 and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). For this reason, data was collected in ten (10) subjects in Cohort 1 and fourteen (14) subjects in Cohort 2 on Day 84. In addition, data not collected for a few subjects (missing data or site error). | mg/dL | MEAN |
| SECONDARY | Daily Dose of Oral Calcium and Active Vitamin D - Part C | Day 28 and Day 43 | * One (1) subject dropped out in Cohort 2 prior to the extension phase. In addition to this subject, two (2) subjects from Cohort 1 and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). For this reason, data was collected in ten (10) subjects in Cohort 1 and fourteen (14) subjects in Cohort 2 on Day 84.~* On Day 84, one (1) patient in Cohort 1 was mistakenly given vitamin D. This patient is included in the nine (9) patients taking no vit D on Day 84. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Calcium Excretion Rate 24h- Part C | Day 1, Day 14, Day 28 and Day 84 | One (1) subject dropped out in Cohort 2 prior to the extension phase. In addition to this subject, two (2) subjects from Cohort 1 and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). For this reason, data was collected in ten (10) subjects in Cohort 1 and fourteen (14) subjects in Cohort 2 on Day 84. In addition, data not collected for a few subjects (missing data or site error). | mg/24h | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT05239221/outcomes