Bosutinib For Autosomal Dominant Polycystic Kidney Disease
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01233869
First received: October 28, 2010
Last updated: October 27, 2014
Last verified: October 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Kidney, Autosomal Dominant |
Drug: Bosutinib Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
polycystic kidney disease
MedlinePlus related topics:
Kidney Diseases
Drug Information available for:
Bosutinib
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Annualized rate (%) of kidney enlargement relative to placebo [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Safety endpoints to include incidence of AEs and SAEs, changes in laboratory test results, including ECGs, and changes in vital signs [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Effect of treatment with bosutinib on renal function evaluations including blood urea nitrogen and serum and urine creatinine. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Time to first occurence (or worsening) of clinical measures of disease activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Serum concentrations of bosutinib will be measured, PK parameters (Cmax, Tmax, AUCt, Cl/F, Vz/F, t1/2 and R) will be calculated [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Subject-reported, disease specific quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 172 |
| Study Start Date: | December 2010 |
| Study Completion Date: | September 2014 |
| Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort A |
Drug: Bosutinib
Once daily oral dose of 200 mg of bosutinib
|
| Experimental: Cohort B |
Drug: Bosutinib
Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
|
| Placebo Comparator: Cohort C |
Drug: Placebo
Once daily oral dose of placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233869
Show 70 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233869
Show 70 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01233869 History of Changes |
| Other Study ID Numbers: | B1871019, 3160A7-2211, 2010-023017-65 |
| Study First Received: | October 28, 2010 |
| Last Updated: | October 27, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Bosutinib Autosomal Dominant Polycystic Kidney Disease |
Additional relevant MeSH terms:
|
Kidney Diseases Multicystic Dysplastic Kidney Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant |
Congenital Abnormalities Kidney Diseases, Cystic Urogenital Abnormalities Urologic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015