Trial · NCT01233869
Bosutinib For Autosomal Dominant Polycystic Kidney Disease
NCT01233869, Phase 2, Completed, Pfizer; results first posted 2015-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bosutinib For Autosomal Dominant Polycystic Kidney Disease. Trials, record NCT01233869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01233869
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bosutinib For Autosomal Dominant Polycystic Kidney Disease
- NCT number
- NCT01233869
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 172 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Interventions
- Bosutinib, Bosutinib, Placebo
- First posted
- 2010-11-03
- Last updated
- 2016-03-11
- Other registries' IDs
- eudract:2010-023017-65
- Results first posted
- 2015-10-28
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 | Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV]) | The modified intent-to-treat (mITT) population included all participants who were randomized and received at least 2-weeks' worth of treatment and have at least 1 follow-up MRI assessment that was preceded by a 1-month washout of the study drug; n=the number of participants analyzed at that time point in the respective arms. | centimeter cube (cm^3) | MEAN |
| 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 | The mITT population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment; n=the number of participants analyzed at that time point in the respective arms. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Time to First Occurrence or Worsening of Hypertension | Baseline up to Month 25 (end of ITPV) | The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement). | days | NUMBER |
| SECONDARY | Time to First Occurrence or Worsening of Back and/or Flank Pain | Baseline up to Month 25 (end of ITPV) | The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement). | days | NUMBER |
| SECONDARY | Time to First Occurrence of Gross Hematuria | Baseline up to Month 25 (end of ITPV) | The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement). | days | NUMBER |
| SECONDARY | Time to First Occurrence of Proteinuria | Baseline up to Month 25 (end of ITPV) | The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement). | days | NUMBER |
| SECONDARY | Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days | Baseline up to Month 25 (end of ITPV) | The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement). | days | NUMBER |
| SECONDARY | Number of Participants With High Blood Urea Nitrogen (BUN) Levels | Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV) | The safety analysis population included all participants who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With High Serum Creatinine (SCr) Levels | Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV) | The safety analysis population included all participants who received at least 1 dose of study drug. | participants | NUMBER |
| 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) | The pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group263
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 | Bosutinib 200 mg/Day | Baseline (n=27,6,21,33) | 1686.38 | Standard Deviation 944.30 | centimeter cube (cm^3) |
| Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 | Bosutinib 400 mg/Day | Baseline (n=27,6,21,33) | 1418.96 | Standard Deviation 629.34 | centimeter cube (cm^3) |
| Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 | Bosutinib 400/200 mg/Day | Baseline (n=27,6,21,33) | 1487.48 | Standard Deviation 531.96 | centimeter cube (cm^3) |
| Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 | Placebo | Baseline (n=27,6,21,33) | 1670.33 | Standard Deviation 640.69 | centimeter cube (cm^3) |
| Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 | Bosutinib 200 mg/Day | CFB at Month 25 (n=23,3,20,30) | 85.05 | Standard Deviation 231.09 | centimeter cube (cm^3) |
| Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 | Bosutinib 400 mg/Day | CFB at Month 25 (n=23,3,20,30) | 102.45 | Standard Deviation 257.30 | centimeter cube (cm^3) |
| Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 | Bosutinib 400/200 mg/Day | CFB at Month 25 (n=23,3,20,30) | -6.18 | Standard Deviation 119.79 | centimeter cube (cm^3) |
| Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 | Placebo | CFB at Month 25 (n=23,3,20,30) | 175.36 | Standard Deviation 191.43 | centimeter cube (cm^3) |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination | Bosutinib 200 mg/Day | CFB at Month 12 (n=26,4,21,31) | -6.38 | Standard Deviation 11.60 | mL/min/1.73m^2 |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination | Bosutinib 400 mg/Day | CFB at Month 12 (n=26,4,21,31) | -7.56 | Standard Deviation 11.27 | mL/min/1.73m^2 |
1 to 10 of 263Source ClinicalTrials.gov
See all 263 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment Period (24 Months) | STARTED | Bosutinib 200 mg/Day | 58 | |
| Initial Treatment Period (24 Months) | STARTED | Bosutinib 400 mg/Day | 31 | |
| Initial Treatment Period (24 Months) | STARTED | Bosutinib 400/200 mg/Day | 24 | |
| Initial Treatment Period (24 Months) | STARTED | Placebo | 56 | |
| Initial Treatment Period (24 Months) | COMPLETED | Bosutinib 200 mg/Day | 34 | |
| Initial Treatment Period (24 Months) | COMPLETED | Bosutinib 400 mg/Day | 3 | |
| Initial Treatment Period (24 Months) | COMPLETED | Bosutinib 400/200 mg/Day | 22 | |
| Initial Treatment Period (24 Months) | COMPLETED | Placebo | 34 | |
| Initial Treatment Period (24 Months) | NOT COMPLETED | Bosutinib 200 mg/Day | 24 | |
| Initial Treatment Period (24 Months) | NOT COMPLETED | Bosutinib 400 mg/Day | 28 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events440
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Bosutinib 200 mg/Day | 7 | 58 | |
| other | Anaemia | Blood and lymphatic system disorders | Bosutinib 400 mg/Day | 4 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Bosutinib 400/200 mg/Day | 5 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 56 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Bosutinib 200 mg/Day | 3 | 58 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Bosutinib 400 mg/Day | 0 | 31 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Bosutinib 400/200 mg/Day | 1 | 24 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Placebo | 0 | 56 | |
| other | Pericardial effusion | Cardiac disorders | Bosutinib 200 mg/Day | 2 | 58 | |
| other | Pericardial effusion | Cardiac disorders | Bosutinib 400 mg/Day | 1 | 31 |
1 to 10 of 440Source ClinicalTrials.gov
See all 440 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosutinib 200 mg/Day | ||
| Total, all-cause mortality | Bosutinib 400 mg/Day | ||
| Total, all-cause mortality | Bosutinib 400/200 mg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Bosutinib 200 mg/Day | 56 | 58 |
| Total, other adverse events | Bosutinib 400 mg/Day | 30 | 31 |
| Total, other adverse events | Bosutinib 400/200 mg/Day | 23 | 24 |
| Total, other adverse events | Placebo | 50 | 56 |
| Total, serious adverse events | Bosutinib 200 mg/Day | 12 | 58 |
| Total, serious adverse events | Bosutinib 400 mg/Day | 4 | 31 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01233869
GET https://conductscience.org/api/trials/v1/NCT01233869/registered?page=2