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

Primary Purpose

Hypertension, Hemodialysis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Digoxin immune fab
Placebo
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Digoxin like substances, digibind, digoxin immune fab, end-stage-renal-disease, marinobufagenin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Toledo Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low

Medium

High

Placebo

Arm Description

0.1mg/kg

0.4mg/kg

1.6 mg/kg

Outcomes

Primary Outcome Measures

Blood pressure

Secondary Outcome Measures

Marinobufagenin levels

Full Information

First Posted
February 26, 2009
Last Updated
May 23, 2012
Sponsor
National Institute on Aging (NIA)
Collaborators
University of Toledo Health Science Campus
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1. Study Identification

Unique Protocol Identification Number
NCT00852787
Brief Title
Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease
Official Title
Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)
Collaborators
University of Toledo Health Science Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hemodialysis
Keywords
Digoxin like substances, digibind, digoxin immune fab, end-stage-renal-disease, marinobufagenin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low
Arm Type
Experimental
Arm Description
0.1mg/kg
Arm Title
Medium
Arm Type
Experimental
Arm Description
0.4mg/kg
Arm Title
High
Arm Type
Experimental
Arm Description
1.6 mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Digoxin immune fab
Other Intervention Name(s)
Digibind
Intervention Description
Intravenously one time
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenously one time
Primary Outcome Measure Information:
Title
Blood pressure
Time Frame
Screening, and 24-hour period after first infusion and after second infusion
Secondary Outcome Measure Information:
Title
Marinobufagenin levels
Time Frame
Screening, and after first and second infusions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak Malhotra, MD, PhD
Organizational Affiliation
University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18542120
Citation
Bagrov AY, Shapiro JI. Endogenous digitalis: pathophysiologic roles and therapeutic applications. Nat Clin Pract Nephrol. 2008 Jul;4(7):378-92. doi: 10.1038/ncpneph0848. Epub 2008 Jun 10.
Results Reference
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PubMed Identifier
15970476
Citation
Mohmand B, Malhotra DK, Shapiro JI. Uremic cardiomyopathy: role of circulating digitalis like substances. Front Biosci. 2005 Sep 1;10:2036-44. doi: 10.2741/1679.
Results Reference
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PubMed Identifier
19008721
Citation
Fedorova OV, Simbirtsev AS, Kolodkin NI, Kotov AY, Agalakova NI, Kashkin VA, Tapilskaya NI, Bzhelyansky A, Reznik VA, Frolova EV, Nikitina ER, Budny GV, Longo DL, Lakatta EG, Bagrov AY. Monoclonal antibody to an endogenous bufadienolide, marinobufagenin, reverses preeclampsia-induced Na/K-ATPase inhibition and lowers blood pressure in NaCl-sensitive hypertension. J Hypertens. 2008 Dec;26(12):2414-25. doi: 10.1097/HJH.0b013e328312c86a.
Results Reference
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Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease

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