Marinobufagenin as a Target for DIGIBIND in Hypertensive... | NCT00852787

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

NCT00852787

Sponsor

National Institute on Aging (NIA)

Status

Unknown status

Last Update Posted

May 25, 2012Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Hypertension
Hemodialysis

Interventions

Digoxin immune fab
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
263-MA-707136-1

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

May 2012Estimated

Completion Date

May 2012Estimated

First Submitted Date

Feb 26, 2009

First Submission Date that Met QC Criteria

Feb 26, 2009

First Posted Date

Feb 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2012

Last Update Posted Date

May 25, 2012Estimated

Name	Class
University of Toledo Health Science Campus	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Digoxin immune fab	Drug	Intravenously one time	High Low Medium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure		Screening, and 24-hour period after first infusion and after second infusion

Secondary Outcomes

Measure	Description	Time Frame
Marinobufagenin levels		Screening, and after first and second infusions

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deepak Malhotra, MD, PhD	University of Toledo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Toledo Medical Center		Toledo	Ohio	43614	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18542120	Background	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.
15970476	Background	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.

ID	Term
D006973	Hypertension
D051436	Renal Insufficiency, Chronic

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases