Trial · NCT04581629
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to 16 months | Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Treatment-emergence was defined as any AE(s) regardless of relationship to investigational medicinal product (IMP), that had an onset or worsened in severity on or after the first dose of IMP. |
| Primary | Period 3: Change From Baseline in Albumin-Corrected Blood Calcium Concentrations (cCa) | Baseline, Week 24 | |
| Primary | Period 3: Rate of Urinary Calcium Excretion | Week 24 | |
| Secondary | Periods 1 and 2: Intact Parathyroid Hormone (iPTH) Concentrations in the Blood | 15 minutes pre-dose on Day 5 of Periods 1 and 2 (Periods were 5 days) | Blood samples were taken for analysis of iPTH concentrations. iPTH concentrations were analyzed via an electrochemiluminescence immunoassay. |
| Secondary | Periods 1 and 2: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Encaleret | Periods 1 and 2: Day 5 (Periods were 5 days) | |
| Secondary | Periods 1, 2 and 3: Maximum Plasma Concentration (Cmax) of Encaleret | Periods 1 and 2: Day 5, Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | |
| Secondary | Periods 1, 2 and 3: Time to Maximum Plasma Concentration (Tmax) of Encaleret | Periods 1 and 2: Day 5; Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | |
| Secondary | Periods 2 and 3: Change From Baseline in Blood Calcium Concentration (cCa) | Period 2: Baseline, Day 5 (Period was 5 days), Period 3: Baseline, Week 24 (Period was 24 weeks) | Data values presented are for the change from baseline for the average values at the specified timepoints/visits. |
| Secondary | Period 3: Urinary Calcium Clearance as Assessed by Fractional Excretion | Period 3: Week 24, 15 minutes pre-dose (Period was 24 weeks) | Fractional Excretion of Calcium was derived as (Urine Calcium at the interval considered \* Serum Creatinine at the end of the interval considered)/(Serum Calcium at the end of the interval considered \* Urine Creatinine at the interval considered) and is presented as percentage. |
| Secondary | Periods 1, 2 and 3: Urinary Calcium Clearance as Assessed by 24-Hour Total Excretion | Periods 1 and 2: Day 5; Period 3, Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | |
| Secondary | Periods 1, 2 and 3: Renal Function as Assessed by Estimated Glomerular Filtration Rate (eGFR) | Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose) (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | eGFR was calculated using Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) formula (mL/min/1.73m\^2) = 141 x min (SCr/K, 1)\^α x max(SCR /K,1)-1.209 x 0.993Age x 1.018 \[if female\] x 1.159 \[if Black\], where SCr is the serum creatinine (mg/dL), K = 0.7 for female and 0.9 for males, α is -0.329 for female and -0.411 for males. |
| Secondary | Periods 1, 2 and 3: Serum Levels of 1,25-(OH)2 Vitamin D | Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | |
| Secondary | Periods 1, 2 and 3: Magnesium, Phosphorus, and Creatinine Levels as Assessed by Blood Sample Examinations | Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | |
| Secondary | Periods 1, 2 and 3: Creatinine, Phosphorus, Magnesium, and Citrate Total Excretion Levels as Assessed by Urine Sample Examinations | Periods 1 and 2: Day 5 (0-24h post-dose), Period 3: Week 24 (0-24h post-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | |
| Secondary | Periods 1, 2 and 3: pH as Assessed by Urine Sample Examinations | Periods 1 and 2: Day 5 (0-24 hours post-dose), Period 3: Week 24: (0-24 hours post-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | |
| Secondary | Periods 1, 2 and 3: Potassium and Sodium Total Excretion Levels as Assessed by Urine Sample Examinations | Periods 1 and 2: Day 5 (0-24h post-dose), Period 3: Week 24 (0-24h post-dose); (Period was 5 days for periods 1 and 2; 24 weeks for period 3) | |
| Secondary | Periods 1, 2 and 3: Cyclic Adenosine Monophosphate (cAMP) Total Excretion Levels as Assessed by Urine Sample Examinations | Periods 1 and 2: Day 5 (0-4h post-dose), Period 3: Week 24 (0-4h post dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | |
| Secondary | Periods 1, 2 and 3: Bone Resorption Markers as Assessed by Collagen Cross-Linked C-Telopeptide (CTx) | Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3 Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | Blood samples were taken for analysis of bone resorption markers (CTx). |
| Secondary | Periods 1, 2 and 3: Bone Formation Markers as Assessed by Blood Procollagen Type 1 N-Propeptide (P1NP) | Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3 Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3) | Blood samples were taken for analysis of bone formation markers (P1NP). |
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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