Phase 2
Completed N=169
Bosutinib For Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney, Autosomal Dominant
Source: ClinicalTrials.gov NCT01233869 ↗
Enrolled (actual)
169
Serious AEs
16.0%
Results posted
Oct 2015
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.