Trial · NCT03237065
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL) | Baseline to day 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL) | Baseline to day 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | days | MEDIAN |
| SECONDARY | Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL) | Baseline to day 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | mg/dL | MEAN |
| SECONDARY | Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | Percentage change from baseline | MEAN |
| SECONDARY | Change From Baseline in Fractional Phosphate Urinary Excretion | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | percentage excreted | MEAN |
| SECONDARY | Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | pg/mL | MEAN |
| SECONDARY | Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | RU/mL | MEAN |
| SECONDARY | Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | ng/mL | MEAN |
| SECONDARY | Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | pg/mL | MEAN |
| SECONDARY | Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | ng/mL | MEAN |
| SECONDARY | Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | pg/mL | MEAN |
| SECONDARY | Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product | mg/dL | MEAN |
| SECONDARY | Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions | Baseline to day 35 | Safety analysis set: included all subjects who received at least one dose of the investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Intention-To-Treat (ITT) analysis set: included all randomised subjects. | g/dL per g of iron | MEAN |
| SECONDARY | Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Intention-To-Treat (ITT) analysis set: included all randomised subjects. | ng/mL | MEAN |
| SECONDARY | Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35 | Baseline, days 1, 7, 8, 14, 21, and 35 | Intention-To-Treat (ITT) analysis set: included all randomised subjects. | percentage of saturation | MEAN |
| POST_HOC | Incidence of S-phosphate Level ≤1.0 mg/dL at Any Time From Baseline to Day 35 | Baseline to day 35 | Participants | COUNT_OF_PARTICIPANTS |
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/NCT03237065/outcomes