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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00852787
• Other study ID #: AG0115
• Secondary ID: 263-MA-707136-1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 26, 2009
• Last updated: May 23, 2012
• Start date: April 2009
• Est. completion date: May 2012

Study information

• Verified date: December 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis
• Hypertension
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Digoxin immune fab
Intravenously one time
• Placebo
Intravenously one time

Locations

Country	Name	City	State
United States	University of Toledo Medical Center	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)	University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

References & 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. Review. — View 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. — View Citation

Mohmand B, Malhotra DK, Shapiro JI. Uremic cardiomyopathy: role of circulating digitalis like substances. Front Biosci. 2005 Sep 1;10:2036-44. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		Screening, and 24-hour period after first infusion and after second infusion	No
Secondary	Marinobufagenin levels		Screening, and after first and second infusions	No