Status:
UNKNOWN
Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease
Lead Sponsor:
National Institute on Aging (NIA)
Collaborating Sponsors:
University of Toledo Health Science Campus
Conditions:
Hypertension
Hemodialysis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to examine the effects of the digibind drug on hemodialysis patients with high blood pressure. Digibind is used to treat toxicity from digoxin and digoxin-like molecules w...
Detailed Description
High blood pressure is a very common problem in patients with kidney disease. Researchers have noted that there are certain molecules in the blood of these patients that may be contributing to the hig...
Eligibility Criteria
Inclusion
- Aged 18-75 years of age
- On hemodialysis with predialysis BP \> 150/90 but ≤ 180/110
- On at least one anti-hypertensive medication for 6 consecutive readings
- Able to have blood pressure measured in an arm
- Women of child bearing potential must not be pregnant; must use contraception during the study and for one month after the study
- Receiving adequate dialysis (KT/V \> 1.2)
- Compliant with the dialysis schedule and duration
Exclusion
- Pregnant or nursing women
- Arm blood pressure is not possible to obtain
- Currently on digitalis
- On any Digibind-type product in the past
- History of allergies to antibiotics
- History of asthma
- Medical or psychiatric disorders which are unstable or which might interfere with study assessments or safe participation in the study
- History of use of, or evidence of need for, digitalis-like products
- Inability to understand or provide informed consent
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00852787
Start Date
April 1 2009
End Date
May 1 2012
Last Update
May 25 2012
Active Locations (1)
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1
University of Toledo Medical Center
Toledo, Ohio, United States, 43614