Trial · NCT03364738
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and Less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24 | At Week 24 | Percentage of participants who achieved ACSC values \>= to range of 1.875 mmol/L and \<= ULN at Week 24 was reported. |
| Primary | Percentage of Participants With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT]) | At Week 52 (EOT) | Percentage of participants who achieved ACSC values \>= to range of 1.875 mmol/L and \<= ULN at Week 52 (EOT) was reported. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration to end of study (Week 56) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, and is an important medical event. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. |
| Primary | Number of Participants With Clinically Significant Change in Clinical Laboratory Values | From start of study drug administration to end of study (Week 56) | Clinical laboratory assessment included hematology, serum chemistry, urine chemistry and urinalysis. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any changes in clinical laboratory results which were deemed clinically significant by the investigator was reported. |
| Primary | Number of Participants With Clinically Significant Change in Vital Sign | From start of study drug administration to end of study (Week 56) | Vital sign parameters included: temperature, pulse rate, respiration rate, systolic and diastolic blood pressure. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any changes in vital signs which were deemed clinically significant by the investigator was reported. |
| Primary | Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters | From start of study drug administration to end of study (Week 56) | Twelve-lead ECGs was performed in triplicate with a minimum 2-minute gap between traces. The participant rested in the supine position for at least 5 minutes before collecting the ECG. Assessment of ECG parameters included: heart rate, RR interval, PR interval, QRS interval, QT interval, and QTc interval. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any change in ECG assessments which were deemed clinically significant by the investigator was reported. |
| Primary | Number of Participants With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values | From start of study drug administration to end of study (Week 56) | eGFR was calculated using the chronic kidney disease epidemiology (CDK-epi) formula. Clinical significance was judged by the investigator based upon the out of range values of standard range set for parameter. Any change in eGFR assessments which were deemed clinically significant by the investigator was reported. |
| Primary | Number of Participants With Clinically Significant Change in Serum Creatinine Value | From start of study drug administration to end of study (Week 56) | eGFR was assessed by measuring serum creatinine. Serum creatinine level was obtained directly from laboratory results. Clinical significance was judged by the investigator based upon the out of range values of standard range set for parameter. Any change in serum creatinine assessments which were deemed clinically significant by the investigator was reported. |
| Primary | Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 24 | Week 24 | Number of participants with positive anti-parathyroid hormone antibodies at Week 24 was reported. |
| Primary | Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 52 (EOT) | Week 52 (EOT) | Number of participants with positive anti-parathyroid hormone antibodies at Week 52 (EOT) was reported. |
| Secondary | Change From Baseline in Albumin Corrected Serum Calcium (ACSC) Concentration at Weeks 24 and 52 (EOT) | Baseline, Weeks 24 and 52 (EOT) | Change from baseline in ACSC concentration at Weeks 24 and 52 (EOT) was reported. |
| Secondary | Change From Baseline in Serum Phosphate Concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) | Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) | Change from baseline in serum phosphate concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) was reported. |
| Secondary | Change From Baseline in ACSC-phosphate Product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) | Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) | Change from baseline in ACSC-phosphate product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) was reported. Here "mmol\^2/L\^2" is abbreviated as millimoles square per liter square. |
| Secondary | Change From Baseline in 24-hour Urine Calcium Excretion at Weeks 16, 32 and 52 (EOT) | Baseline, Weeks 16, 32 and 52 (EOT) | Change from baseline in 24-hour urine calcium excretion at Weeks 16, 32 and 52 (EOT) was reported. |
| Secondary | Percentage Change From Baseline in Prescribed Supplemental Oral Calcium Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (End of Study [EOS]) | Baseline and at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) | Percentage change from baseline in prescribed supplemental oral calcium dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) were reported. |
| Secondary | Percentage Change From Baseline in Prescribed Supplemental Active Vitamin D Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) | Baseline, Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) | Percentage change from baseline in prescribed supplemental oral calcium dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) were reported. |
| Secondary | Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase at Weeks 8, 24 and 52 (EOT) | Baseline, Weeks 8, 24 and 52 (EOT) | Percentage change from baseline in serum bone-specific alkaline phosphatase at Weeks 8, 24 and 52 (EOT) was reported. |
| Secondary | Percentage Change From Baseline in Serum Osteocalcin at Weeks 8, 24 and 52 (EOT) | Baseline, Weeks 8, 24 and 52 (EOT) | Percentage change from baseline in serum osteocalcin at Weeks 8, 24 and 52 (EOT) was reported. |
| Secondary | Percentage Change From Baseline in Procollagen 1 N-Terminal Propeptide at Weeks 8, 24 and 52 (EOT) | Baseline, Weeks 8, 24 and 52 (EOT) | Percentage change from baseline in procollagen 1 N-terminal propeptide at Weeks 8, 24 and 52 (EOT) was reported. |
| Secondary | Percentage Change From Baseline in Type I Collagen C-Telopeptides at Weeks 8, 24 and 52 (EOT) | Baseline, Weeks 8, 24 and 52 (EOT) | Percentage change from baseline in type I collagen C-telopeptides at Week 8, 24 and 52 (EOT) was reported. |
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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