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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Institute on Aging (NIA).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Toledo Health Science Campus
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00852787
First received: February 26, 2009
Last updated: May 23, 2012
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
Hemodialysis
 Drug: Digoxin immune fab
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Blood pressure [ Time Frame: Screening, and 24-hour period after first infusion and after second infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Marinobufagenin levels [ Time Frame: Screening, and after first and second infusions ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low
0.1mg/kg
 Drug: Digoxin immune fab
Intravenously one time
Other Name: Digibind
Experimental: Medium
0.4mg/kg
 Drug: Digoxin immune fab
Intravenously one time
Other Name: Digibind
Experimental: High
1.6 mg/kg
 Drug: Digoxin immune fab
Intravenously one time
Other Name: Digibind
Placebo Comparator: Placebo Drug: Placebo
Intravenously one time

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852787

Locations
United States, Ohio
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
National Institute on Aging (NIA)
University of Toledo Health Science Campus
Investigators
Principal Investigator: Deepak Malhotra, MD, PhD University of Toledo
  More Information

Publications:

Responsible Party: Deepak Malhotra, MD, PhD, University of Toledo
ClinicalTrials.gov Identifier: NCT00852787     History of Changes
Other Study ID Numbers: AG0115, 263-MA-707136-1
Study First Received: February 26, 2009
Last Updated: May 23, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Digoxin like substances
digibind
digoxin immune fab
end-stage-renal-disease
marinobufagenin

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Digoxin
Bufanolides
Marinobufagenin
 Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on June 17, 2013