EUCTR2010-023017-65-SE进行中（未招募）不适用
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)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- •2. Males and females, aged =18 years to 50 years at the time of consent.
- •3. Documented diagnosis of ADPKD by renal ultrasound cyst criteria based on the Unified Criteria for Ultrasonographic Diagnosis of ADPKD. A family history of ADPKD is not required to support diagnosis by ultrasound criteria. Alternatively, the diagnosis of ADPKD may be based on PKD 1 or PKD 2 genotype findings as documented in the medical record.
- •4. Total kidney volume =750 cc, as measured by centrally evaluated MRI.
- •5. Left ventricular ejection fraction by echocardiogram or MUGA =50% at screening.
- •6. All women of childbearing potential must have two negative pregnancy test results before administration of study drug. Women of childbearing potential must agree to use two highly effective methods of contraception as described in the protocol for at least 14 days prior to the first dose of study medication and continue until 28 days after dosing. A subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
- •7. Men willing to use two highly effective methods of contraception as described in the protocol throughout the active treatment phase of the study and for 28 days after the last dose of study drug. Any pregnancy that occurs in the female partner of a male subject in the study must be reported if it occurs at any time during the active treatment phase of the study or for 28 days after the last dose of study drug.
- •8. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1. Weight <40 kg or >125 kg.
- •2. Women who are pregnant or breastfeeding or women who intend to become pregnant in the next two years.
- •3. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 for primary treatment population. Subjects with moderate renal impairment (defined as 30 mL/min/1.73m2 = eGFR =50mL/min/1.73m2) are excluded (from enrollment in an exploratory population) until results from a separate renal impairment PK study (study B1871020) demonstrate no substantial impact of renal impairment on bosutinib PK. Subjects with an eGFR<30 mL/min/1.73m2 will be excluded.
- •4. Abnormal urinalysis showing cellular casts.
- •5. Biopsy proven renal disease other than ADPKD.
- •6. Chronic back and/or flank pain requiring daily or near daily pain medication over the preceding month.
- •7. Documented renal vascular disease.
- •8. Documented systemic illness with renal involvement.
- •9. Creatine supplements within 3 months of the baseline visit.
- •10. Uncontrolled hypertension (defined as systolic blood pressure =140 or diastolic blood pressure =90 mm Hg).
- •11. Uncontrolled diabetes mellitus as evidenced by screening assessments and/or recent medical record.
- •12. Medical history or diagnosis of immunodeficiency.
- •13. Autoimmune disease not in remission or requiring ongoing treatment with immunosuppressive medication.
- •14. Increased ALT and/or AST >2.5 x the upper limit of normal.
- •15. Total bilirubin >2 x the upper limit of normal (unless associated with Gilbert’s syndrome).
- •16. Grade 2 or higher abnormalities of serum sodium [sodium >150 or <130 mmol/l].
- •17. Uncorrected hypomagnesemia or hypokalemia [serum magnesium or serum potassium < lower limit of normal].
- •18. Grade 2 or higher elevation of serum potassium or serum magnesium [serum potassium >5.5 or serum magnesium >3.0 mg/dl (or >1.23 mmol/l)].
- •19. Hemoglobin <9.0 gm/dl.
- •20. Platelet count <100,000/microliter.
- •21. Congenital absence of a kidney or prior surgical resection of a kidney for any reason.
- •22. Clinically significant or unstable cardiac disease (eg, unstable angina, recent myocardial infarction, clinically significant arrhythmia requiring treatment, uncontrolled congestive heart failure, etc).
- •23. Subjects with any pre dose corrected QT interval (QTc) =450 msec based on any one of the machine read tracing using Fridericia’s formulae obtained at screening. Any decision to retest a subject must first be discussed with the Pfizer Medical Monitor. If a repeat QTcF interval obtained pre-dose is =450 msec, the subject is excluded from enrollment.
- •24. History of prolonged QTc interval or additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
- •25. History or evidence of infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- •26. Past or present malignancy (with the exception of adequately treated, localized basal cell or squamous cell carcinoma of the skin).
- •27. Use of any investigational drug or investigational biologic compound within 4 weeks prior to the screening visit or during the screening period.
- •28. Participation in any interventional studies within 4 weeks prior to the screening visit and/or during study participation.
- •29. Any previous exposure to the bosutinib study drug, including previous participation in a bosutinib clinical study, or receipt of other therapies int
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