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

National Institutes of Health (NIH) logo

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems