Overview

Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease

Status:
Unknown status
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
All
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 which may contribute to high blood pressure.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute on Aging (NIA)
Collaborator:
University of Toledo Health Science Campus
Treatments:
Bufanolides
Digoxin
Marinobufagenin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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