Trial · NCT02964273
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase A: Change From Baseline in Spot Urine Osmolality (Pre-morning Dose) | Baseline, and Week 1 of Phase A | Urine osmolality is a measure of urine concentration, measured by osmometer, which evaluates the freezing point depression of a solution and supplies results as milliosmoles per kilogram of water. Spot urine osmolality was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), and Week 1 for all participants. Sample was taken after the first morning's void and was provided as a mid-stream, clean catch sample. All participants were fasting. |
| Primary | Phase A: Change From Baseline in Specific Gravity (Pre-morning Dose) | Baseline, and Week 1 of Phase A | Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Spot urine sample for determination of specific gravity was collected immediately prior to morning dosing for Day 1 (Baseline), and Week 1 for all participants. Sample was taken after the first morning's void and was provided as a mid-stream, clean catch sample. All participants were fasting. |
| Secondary | Phase A: Percent Change From Phase A Baseline in Height-Adjusted Total Kidney Volume (htTKV) as Measured by Magnetic Resonance Imaging (MRI) | Baseline, and Month 12 of Phase A | htTKV is used in participants with autosomal dominant polycystic kidney disease to predict the onset of renal insufficiency. |
| Secondary | Phase A and B: Mean 24-hour Fluid Balance Prior to Week 1 | Prior to Week 1 in Phase A and B | Participants were instructed to record all fluid taken and all urine output for the 24-hour period. |
| Secondary | Phase A: Change From Baseline in Renal Function (Estimated Glomerular Filtration Rate [eGFR] by Schwartz Formula) at Each Clinic Visit in Phase A | Phase A Baseline, Months 1, 6, and 12 | Renal function was assessed by estimated eGFR calculated by the Schwartz formula (eGFR = 0.413 × height \[cm\] /serum creatinine mg/dL), expressed as mean change in eGFR at the specified time points. The units for the data reported are milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2). The baseline was the evaluation done at Week 1 in Phase A for this outcome measure. |
| Secondary | Phase B: Change From Phase B Baseline in Renal Function (eGFR by Schwartz Formula) at Each Clinic Visit in Phase B | Phase B Baseline, Week 1, Months 1, 6, 12, 18, and 24 | Renal function was assessed by estimated eGFR calculated by the Schwartz formula (eGFR = 0.413 × height \[cm\] /serum creatinine mg/dL), expressed as mean change in eGFR at the specified time points. |
| Secondary | Phase B: Percent Change From Phase B Baseline in htTKV as Measured by MRI at Month 12 and Month 24 | Phase B Baseline, Months 12 and 24 | htTKV is used in participants with autosomal dominant polycystic kidney disease to predict the onset of renal insufficiency. |
| Secondary | Phase A: 24-hour Urine Volume | 24 hours post dose after Month 1 on study medication in Phase A | Urine volume refers to the quantity of urine produced per unit of time. |
| Secondary | Phase A: 24-hour Fluid Intake | 24 hours post dose after Month 1 on study medication in Phase A | Daily fluid intake (total water) is defined as the amount of water consumed from foods, plain drinking water, and other beverages. |
| Secondary | Phase A: 24-hour Fluid Balance | 24 hours post dose after Month 1 on study medication in Phase A | Fluid balance is a term used to describe the balance of the input and output of fluids in the body to allow metabolic processes to function correctly. |
| Secondary | Phase A: 24-hour Sodium Clearance | 24 hours post dose after Month 1 on study medication in Phase A | Data was categorized and reported based on the total daily dose for the given time point of 0-24 hours. |
| Secondary | Phase A: 24-hour Creatinine Clearance | 24 hours post dose after Month 1 on study medication in Phase A | Creatinine is produced from the metabolism of protein, when muscles burn energy. Most creatinine is filtered out of the blood by the kidneys and excreted in urine. The creatinine clearance value is determined by measuring the concentration of endogenous creatinine (that which is produced by the body) in both plasma and urine. Data was categorized and reported based on the total daily dose for the given time point of 0-24 hours. |
| Secondary | Phase A: 24-hour Free Water Clearance | 24 hours post dose after Month 1 on study medication in Phase A | Data was categorized and reported based on the total daily dose for the given time point of 0-24 hours. |
| Secondary | Phase A: Percentage of Each Tanner Stage by Gender and Age Compared to Normative Populations | At Baseline, Months 6 and 12 of Phase A | Tanner stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Only those categories with at least one participant with event are reported. |
| Secondary | Phase B: Percentage of Each Tanner Stage by Gender and Age Compared to Normative Populations | At Baseline, Months 6, 12, 18, and 24 of Phase B | Tanner stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Only those categories with at least one participant with event are reported. |
| Secondary | Phase A: Change From Baseline in Growth Percentile by Gender and Age | At Baseline, Months 6 and 12 of Phase A | The growth percentile was based on the assessment of height and weight. |
| Secondary | Phase B: Change From Baseline in Growth Percentile by Gender and Age | At Baseline, Months 6, 12, 18, and 24 of Phase B | The growth percentile was based on the assessment of height and weight. |
| Secondary | Phase A: Change From Baseline in Creatinine Value | Baseline, Week 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Follow Up Day 7, End of Treatment, and Last Visit | Phase A Baseline is the last pre-dose evaluation. The Last Visit is the last available post-baseline evaluation including early term. As prespecified in the protocol, data for safety is reported by the treatment group (Phase A: Tolvaptan and Phase A: Placebo) |
| Secondary | Phase B: Change From Baseline in Creatinine Value | Baseline, Week 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, Follow Up Day 7, End of Treatment, and Last Visit | Phase B Baseline is the last evaluation prior to the first dose in Phase B. The Last Visit is the last available post-baseline evaluation including early term. As prespecified in the protocol, data for safety is reported by the treatment group (Phase B: Prior Tolvaptan and Phase B: Prior Placebo). |
| Secondary | Phase A and B: Percentage of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | From first dose of study drug up to 14 days post last dose (up to approximately 37 months) | Vital sign measurements included measurements of respiratory rate, blood pressure, body temperature and pulse. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance. Only those categories with at least one participant with event are reported. As prespecified in the protocol, data for safety is reported by the treatment group (Phase A: Tolvaptan, Phase A: Placebo, Phase B: Prior Tolvaptan and Phase B: Prior Placebo). |
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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