Trial · NCT03001011
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Serum Phosphorus at Week 8 | Baseline, Week 8 | Baseline of serum phosphorus value was the last serum phosphorus level obtained before the first double-blind investigational medicinal product (IMP) dosing. Missing Week 8 data were imputed by last observation carried forward \[LOCF\] method. |
| Secondary | Change From Baseline in Total Cholesterol at Week 8 | Baseline, Week 8 | Missing Week 8 data were imputed by LOCF method. |
| Secondary | Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 | Baseline, Week 8 | Missing Week 8 data were imputed by LOCF method. |
| Secondary | Change From Baseline in Calcium-Phosphorus Product at Week 8 | Baseline, Week 8 | Missing Week 8 data were imputed by LOCF method. |
| Secondary | Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8 | Baseline, Week 8 | Missing Week 8 data were imputed by LOCF method. |
| Secondary | Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8 | Week 8 | Missing Week 8 data were imputed by LOCF method. |
| Secondary | Change From Baseline in Serum Phosphorus Level at Week 4 | Baseline, Week 4 | Missing Week 4 data were imputed by LOCF method. |
| Secondary | Number of Participants With Treatment Emergent Adverse Event | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an Adverse Event (AE) without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during TEAE period. On-treatment period was defined as the (time from the first dose of IMP to the last dose of IMP+3 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Criteria for potentially clinically significant abnormalities: * Hemoglobin: \<=115 g/L (Male\[M\]) or \<=95 g/L (Female \[F\]); \>=185 g/L (M) or \>=165 g/L (F); Decrease from baseline (DFB) \>=20 g/L * Hematocrit: \<=0.37 v/v (M) or \<=0.32 v/v (F); \>=0.55 v/v (M) or \>=0.5 v/v (F) * Red blood cells (RBC): \>=6 Tera/L * Platelets: \<100 Giga/L; \>=700 Giga/L * White blood cells (WBC): \<3.0 Giga/L (Non-Black \[NB\]) or \<2.0 Giga/L (Black \[B\]); \>=16.0 Giga/L * Neutrophils: \<1.5 Giga/L (NB) or \<1.0 Giga/L (B); \<1.0 Giga/L * Lymphocytes: \>4.0 Giga/L * Monocytes: \>0.7 Giga/L * Basophils: \>0.1 Giga/L * Eosinophils: \>0.5 Giga/L or \>upper limit of normal (ULN) (if ULN \>=0.5 Giga/L) |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Criteria for potentially clinically significant abnormalities: * Glucose: \<=3.9 mmol/L and \< lower limits of normal (LLN); \>=11.1 mmol/L (unfasted \[unfas\]) or \>=7 mmol/L (fasted \[fas\]) * Triglycerides: \>=4.6 mmol/L * Albumin: \<= 25 g/L. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Criteria for potentially clinically significant abnormalities: Sodium: \<=129 millimoles (mmol)/L; \>=160 mmol/L Potassium: \<3 mmol/L; \>=5.5 mmol/L Chloride: \<80 mmol/L; \>115 mmol/L. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Criteria for potentially clinically significant abnormalities: Creatinine: \>=150 micromol/L; \>=30% change from baseline, \>=100% change from baseline Creatinine clearance: \<15 mL/min; \>=15 to \<30 mL/min; \>=30 to \<60 mL/min; \>=60 to \<90 mL/min Blood urea nitrogen: \>=17 mmol/L Uric acid: \<120 micromol/L; \>408 micromol/L Glomular Filtration Rate (GFR): \< 15 mL/min/1.73m\^2, \>= 15 - \< 30 mL/min/1.73m\^2, \>= 30 - \< 60 mL/min/1.73m\^2, \>= 60 - \< 90 mL/min/1.73m\^2. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Criteria for potentially clinically significant abnormalities: Alanine Aminotransferase (ALT): \>3 ULN; \>5 ULN; \>10 ULN; Aspartate aminotransferase (AST): \>3 ULN. |
| Secondary | Number of Participants With Clinically Significant Vital Signs Abnormalities | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Criteria for potentially clinically significant vital sign abnormalities: Systolic blood pressure (SBP) supine: \<=95 millimeters of mercury (mmHg) and DFB \>=20 mmHg; \>=160 mmHg and increase from baseline (IFB) \>=20 mmHg Diastolic blood pressure (DBP) supine: \<=45 mmHg and DFB \>=10 mmHg; \>=110 mmHg and IFB \>=10 mmHg Heart rate (HR) supine: \<=50 beats per minute (bpm) and DFB \>=20 bpm; \>=120 bpm and IFB \>=20 bpm Weight: \>=5% DFB; \>=5% IFB. |
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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