NCT00852787

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Institute on Aging (NIA) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Hemodialysis

Interventions

Type	Name	Description
DRUG	Digoxin immune fab	Intravenously one time
DRUG	Placebo	Intravenously one time

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-02-27
• Last updated: 2012-05-25

Locations

1 site across 1 country: United States