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

National Institutes of Health (NIH)

Status and phase: Unknown; Phase 4

Conditions: Hypertension; Hemodialysis

Treatments: Drug: Placebo; Drug: Digoxin immune fab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00852787

263-MA-707136-1

AG0115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 4 patient groups, including a placebo group

Low

Experimental group

Description:

0.1mg/kg

Treatment:

Drug: Digoxin immune fab

Medium

Experimental group

Description:

0.4mg/kg

Treatment:

Drug: Digoxin immune fab

High

Experimental group

Description:

1.6 mg/kg

Treatment:

Drug: Digoxin immune fab

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo