Trial · NCT01233869
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 | Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 | Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV]) | TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI). |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination | Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination | eGFR was centrally evaluated. Glomerular filtration rate (GFR) is an index of kidney function that describes the flow of filtered fluid through the kidney. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used to calculate eGFR. Month 25 is the end of the ITPV. |
| Secondary | Time to First Occurrence or Worsening of Hypertension | Baseline up to Month 25 (end of ITPV) | The time to first occurrence or worsening of hypertension was observed (defined as the need for increased dose of or need for additional anti-hypertensive medication). The numbers presented correspond to the very first occurrence or worsening of hypertension in that treatment group. |
| Secondary | Time to First Occurrence or Worsening of Back and/or Flank Pain | Baseline up to Month 25 (end of ITPV) | The time to first occurrence or worsening of back and/or flank pain was observed (defined as initial onset of polycystic kidney disease \[PKD\]-related chronic back and/or flank pain; initiation of pain medication treatment for PKD-related chronic back and/or flank pain; addition of a pain medicine for treatment of PKD-related chronic back and/or flank pain; increase in dose of pain medication for treatment of PKD-related chronic back and/or flank pain). The numbers presented correspond to the very first occurrence or worsening of back and/or flank pain in that treatment group. |
| Secondary | Time to First Occurrence of Gross Hematuria | Baseline up to Month 25 (end of ITPV) | Gross hematuria is the presence of blood in the urine (defined as pink, red, or cola-colored urine due to the presence of red blood cells). The numbers presented correspond to the very first occurrence of gross hematuria in that treatment group. |
| Secondary | Time to First Occurrence of Proteinuria | Baseline up to Month 25 (end of ITPV) | Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. The numbers presented correspond to the very first occurrence of proteinuria in that treatment group. |
| Secondary | Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days | Baseline up to Month 25 (end of ITPV) | ESRD is when the kidneys permanently fail to work at a level needed for daily life. No participants developed ESRD during the treatment period, therefore the analysis of the onset of ESRD requiring ≥56 days of dialysis was not performed. |
| Secondary | Number of Participants With High Blood Urea Nitrogen (BUN) Levels | Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV) | A BUN test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high BUN level (\>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV. |
| Secondary | Number of Participants With High Serum Creatinine (SCr) Levels | Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV) | A SCr test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high SCr level (\>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Bosutinib | Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose) | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib | Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose) | |
| Secondary | Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib | Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose) | Area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau=24 hours. |
| Secondary | Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib | Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose) | |
| Secondary | Apparent Oral Clearance (CL/F) of Bosutinib | Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
| Secondary | Apparent Volume of Distribution (Vz/F) of Bosutinib | Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. |
| Secondary | Terminal Elimination Half-Life (t1/2) of Bosutinib | Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose) | t1/2 is the time measured for the plasma concentration to decrease by one half. |
| Secondary | Observed Accumulation Ratio (Rac) of Bosutinib | Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose) | Observed accumulation ratio (Rac) was calculated as AUC from time 0 to 24 hours (Day 15) divided by AUC from time 0 to 24 hours (Day 1). |
| Secondary | Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25 | Baseline and end of ITPV (Month 25) | The KDQoL-36 is a 36-item questionnaire on kidney disease-specific measure of patient-reported quality of life with 5 subscales: physical and mental functioning (items 1-12); burden of kidney disease subscale (items 13-16); symptoms and problems (items 17-28); effects of kidney disease on daily life subscale (items 29-36). The raw scores are transformed linearly to a range of 0 to 100, with higher scores indicating better quality of life. |
| Other | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last study drug administration | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. |
| Other | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | Baseline up to 30 days after last study drug administration | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, RBC morphology, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (coagulation panel, circulating immune complex, and complement activation). |
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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