Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease
This trial is active, not recruiting.
|Treatments||digoxin immune fab, placebo|
|Sponsor||National Institute on Aging (NIA)|
|Collaborator||University of Toledo Health Science Campus|
|Start date||April 2009|
|End date||May 2012|
|Trial size||30 participants|
|Trial identifier||NCT00852787, 263-MA-707136-1, AG0115|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
time frame: Screening, and 24-hour period after first infusion and after second infusion
time frame: Screening, and after first and second infusions
Male or female participants from 18 years up to 75 years old.
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
|Official title||Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease|
|Principal investigator||Deepak Malhotra, MD, PhD|
|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 high blood pressure. In particular these molecules have been labeled as "digoxin-like substances." Digoxin is a drug made from a certain plant that may contribute to high blood pressure. In research animals with kidney failure, it has been noted that the use of Digibind helps to lower the blood pressure in these animals. Digibind is a drug made from sheep that is used to treat the toxicity from digoxin as well as toxicity from molecules similar to digoxin. In this study, volunteers that are on hemodialysis and have high blood pressure will be given a placebo or the digibind drug intravenously on two separate visits. The volunteers will then wear a 24-hour blood pressure monitor and return the following day. Volunteers will receive the Digibind at one visit during the study, and the placebo on the other visit.|
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