Bosutinib For Autosomal Dominant Polycystic Kidney Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01233869
• Date of registration: 28/10/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Bosutinib For Autosomal Dominant Polycystic Kidney Disease
• Scientific title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Date of first enrolment: December 2010
• Target sample size: 172
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01233869
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Canada, Czech Republic, Hungary, Italy, Korea, Republic of, Lithuania, Moldova, Republic of, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Polycystic Kidney, Autosomal Dominant

Intervention(s)

Drug: Placebo

Drug: Bosutinib

Primary Outcome(s)

Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25 [Time Frame: Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])]

Secondary Outcome(s)

Apparent Volume of Distribution (Vz/F) of Bosutinib [Time Frame: 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)]

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib [Time Frame: 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)]

Terminal Elimination Half-Life (t1/2) of Bosutinib [Time Frame: 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)]

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination [Time Frame: Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination]

Number of Participants With High Serum Creatinine (SCr) Levels [Time Frame: Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)]

Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib [Time Frame: 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)]

Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25 [Time Frame: Baseline and end of ITPV (Month 25)]

Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days [Time Frame: Baseline up to Month 25 (end of ITPV)]

Maximum Observed Plasma Concentration (Cmax) of Bosutinib [Time Frame: 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)]

Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib [Time Frame: Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)]

Number of Participants With High Blood Urea Nitrogen (BUN) Levels [Time Frame: Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)]

Time to First Occurrence or Worsening of Back and/or Flank Pain [Time Frame: Baseline up to Month 25 (end of ITPV)]

Time to First Occurrence or Worsening of Hypertension [Time Frame: Baseline up to Month 25 (end of ITPV)]

Time to First Occurrence of Gross Hematuria [Time Frame: Baseline up to Month 25 (end of ITPV)]

Apparent Oral Clearance (CL/F) of Bosutinib [Time Frame: Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)]

Observed Accumulation Ratio (Rac) of Bosutinib [Time Frame: Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)]

Time to First Occurrence of Proteinuria [Time Frame: Baseline up to Month 25 (end of ITPV)]

Secondary ID(s)

B1871019

2010-023017-65

3160A7-2211

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/10/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01233869