Overview

This trial is active, not recruiting.

Conditions hypertension, hemodialysis
Treatments digoxin immune fab, placebo
Phase phase 4
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
0.1mg/kg
digoxin immune fab Digibind
Intravenously one time
(Experimental)
0.4mg/kg
digoxin immune fab Digibind
Intravenously one time
(Experimental)
1.6 mg/kg
digoxin immune fab Digibind
Intravenously one time
(Placebo Comparator)
placebo
Intravenously one time

Primary Outcomes

Measure
Blood pressure
time frame: Screening, and 24-hour period after first infusion and after second infusion

Secondary Outcomes

Measure
Marinobufagenin levels
time frame: Screening, and after first and second infusions

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by National Institute on Aging (NIA).