Status:
COMPLETED
Apixaban in End-stage Kidney Disease : A Pharmacokinetics Study
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
ESRD
Anticoagulant Toxicity
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Apixaban is a novel oral direct factor Xa inhibitor; In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and result...
Detailed Description
RATIONALE Chronic Kidney Disease (CKD) is one of the epidemics of modern times. In the recent National Health and Nutrition Examination Survey (NHANES), the overall prevalence of CKD (stages 1 to 4) ...
Eligibility Criteria
Inclusion
- Patients aged 18 to 85 years
- Treated with maintenance (dialysis vintage \>3 months) thrice weekly hemodialysis
- Written and signed informed consent
Exclusion
- Treated with oral vitamin K antagonists
- Recent (\< 4 weeks prior to informed consent) major surgery
- Recent (\< 4 weeks prior to informed consent) severe bleeding episode requiring blood transfusion and/ or hospitalization
- Concurrent moderate to severe liver dysfunction
- Participation in an interventional study with investigational medication
- For women of childbearing potential the following criteria apply:
- A women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \> 40mIU/mL to confirm menopause.
- Females treated with hormone replacement therapy, (HRT) are likely to have artificially suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH level. The duration of the washout period is a function of the type of HRT used. The duration of the washout period below are suggested guidelines and the investigators should use their judgement in checking serum FSH levels. If the serum FSH level is \>40 mIU/ml at any time during the washout period, the woman can be considered postmenopausal :
- 1 week minimum for vaginal hormonal products (rings, creams, gels)
- 4 week minimum for transdermal products
- 8 week minimum for oral products Other parenteral products may require washout periods as long as 6 months.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study drug.
- Women must not be breastfeeding
- WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug Apixaban plus 5 half-lives of study drug (3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug Apixaban plus 5 half-lives of the study drug (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days post-treatment completion.
- Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancy testing as described in this section.
- Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of \< 1% when used consistently and correctly. At a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:
- Male condoms with spermicide
- Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject's WOCBP partner. Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug
- IUDs, such as ParaGard
- Tubal ligation
- Vasectomy.
- Complete Abstinence Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Female subjects must continue to have pregnancy tests. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence;
Key Trial Info
Start Date :
September 25 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03456648
Start Date
September 25 2016
End Date
August 24 2018
Last Update
October 17 2018
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Vlaams-brabant, Belgium, 3000