Trial · NCT03237065
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL) | Baseline to day 35 | Safety The incidence of hypophosphatemia (defined as s-phosphate \<2 mg/dL) at any time from baseline up to day 35. |
| Secondary | Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL) | Baseline to day 35 | Safety Time with hypophosphatemia (i.e. time with s-phosphate level \< 2.0 mg/dL) from baseline up to day 35. The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was \<2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35. |
| Secondary | Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL) | Baseline to day 35 | Safety Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level \<2.0 mg/dL) on day 35. |
| 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 Absolute \[∆\] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35. |
| 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 Relative \[%\] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35. |
| Secondary | Change From Baseline in Fractional Phosphate Urinary Excretion | Baseline, days 1, 7, 8, 14, 21, and 35 | Safety Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35. Fractional excretion of phosphate (FEPi) is calculated as (\[phosphate in urine X creatinine in serum\]/\[phosphate in serum X creatinine in urine\]) X 100, and the unit is %. |
| 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 Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35. |
| 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 Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35. |
| 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 Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35. |
| 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 Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35. |
| 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 Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35. |
| 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 Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35. |
| 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 Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35. |
| Secondary | Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions | Baseline to day 35 | Safety For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. |
| 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 | Efficacy Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35. |
| 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 | Efficacy Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35. |
| 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 | Efficacy Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35. TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron. |
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.
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