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

Phase 4

• Conditions: Hypertension; Hemodialysis
• Interventions: Drug: Digoxin immune fab; Drug: Placebo

• Registration Number: NCT00852787
• Lead Sponsor: National Institute on Aging (NIA)

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 which may contribute to high blood pressure.

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 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.

Study Timeline

• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Study Start: 2009-04
• Status Verified: 2009-12
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-23
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High	Digoxin immune fab	1.6 mg/kg
Low	Digoxin immune fab	0.1mg/kg
Medium	Digoxin immune fab	0.4mg/kg
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Blood pressure	Screening, and 24-hour period after first infusion and after second infusion

Secondary Outcome Measures

Name	Time	Method
Marinobufagenin levels	Screening, and after first and second infusions

Trial Locations

Locations (1)

University of Toledo Medical Center; 🇺🇸 Toledo, Ohio, United States