Phase 2
N=169
Bosutinib For Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney, Autosomal Dominant
Bottom Line
View on ClinicalTrials.gov: NCT01233869 ↗Enrolled (actual)
169
Serious AEs
16.0%
Results posted
Oct 2015
Primary outcome: Primary: Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 — 1686.38; 1418.96; 1487.48; 1670.33 centimeter cube (cm^3) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bosutinib (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 |
1686.38; 1418.96; 1487.48; 1670.33; 85.05; 102.45 | <0.0001 sig |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination |
-6.38; -7.56; -11.52; 1.30; -8.47; -21.59 | — |
| SECONDARY Time to First Occurrence or Worsening of Hypertension |
15; 180; 90; 30 | — |
| SECONDARY Time to First Occurrence or Worsening of Back and/or Flank Pain |
30; 30; 270; 15 | — |
| SECONDARY Time to First Occurrence of Gross Hematuria |
330; 180; 180; 45 | — |
| SECONDARY Time to First Occurrence of Proteinuria |
360; NA; 270; 540 | — |
| SECONDARY Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days |
NA; NA; NA; NA | — |
| SECONDARY Number of Participants With High Blood Urea Nitrogen (BUN) Levels |
0; 0; 2; 0; 0; 0 | — |
| SECONDARY Number of Participants With High Serum Creatinine (SCr) Levels |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Bosutinib |
32.61; 74.87; 84.57; 68.72; 127.90; 155.00 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib |
3.00; 3.00; 4.86; 3.95; 3.00; 5.00 | — |
| SECONDARY Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib |
437; 1040; 1149; 1059; 2052; 2384 | — |
| SECONDARY Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib |
25.15; 19.60; 50.67 | — |
| SECONDARY Apparent Oral Clearance (CL/F) of Bosutinib |
188.8; 195.0; 167.8 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of Bosutinib |
— | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) of Bosutinib |
— | — |
| SECONDARY Observed Accumulation Ratio (Rac) of Bosutinib |
2.452; 2.280; 2.075 | — |
| SECONDARY Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25 |
84.23; 84.722; 79.43; 74.86; -2.54; -2.08 | — |
Summary
This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 mL/min/1.73m2.
Eligibility Criteria
Inclusion Criteria
- Males and females, 18 to 50 years old at the time of consent.
- Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed).
- Total kidney volume ≥ 750 cc, as measured by centrally evaluated MRI.
Exclusion Criteria
- eGFR < 60 mL/min/1.73m2.
- Uncontrolled hypertension (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg).
- Any previous exposure to the bosutinib test article or receipt of other polycystic kidney disease (PKD) therapies.
Data sourced from ClinicalTrials.gov (NCT01233869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.