NCT00852787

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Apr 2009

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 25, 2012

Status Verified

December 1, 2009

Enrollment Period

3.1 years

First QC Date

February 26, 2009

Last Update Submit

May 23, 2012

Conditions

HypertensionHemodialysis

Keywords

Digoxin like substancesdigibinddigoxin immune fabend-stage-renal-diseasemarinobufagenin

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Screening, and 24-hour period after first infusion and after second infusion

Secondary Outcomes (1)

  • Marinobufagenin levels

    Screening, and after first and second infusions

Study Arms (4)

Low

EXPERIMENTAL

0.1mg/kg

Drug: Digoxin immune fab

Medium

EXPERIMENTAL

0.4mg/kg

Drug: Digoxin immune fab

High

EXPERIMENTAL

1.6 mg/kg

Drug: Digoxin immune fab

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Digoxin immune fabDRUG

Intravenously one time

Also known as: Digibind
HighLowMedium
PlaceboDRUG

Intravenously one time

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Related Publications (3)

  • 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.

    PMID: 18542120BACKGROUND

  • 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.

    PMID: 15970476BACKGROUND

  • 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.

    PMID: 19008721BACKGROUND

MeSH Terms

Conditions

HypertensionRenal Insufficiency, Chronic

Interventions

digoxin antibodies Fab fragments

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Deepak Malhotra, MD, PhD

    University of Toledo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

February 26, 2009

First Posted

February 27, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 25, 2012

Record last verified: 2009-12

Locations

US(1)