Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Ohio
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Toledo, Ohio, United States, 43614
- University of Toledo Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Intravenously one time
|
|
Experimental: Low
0.1mg/kg
|
Intravenously one time
Other Names:
|
|
Experimental: Medium
0.4mg/kg
|
Intravenously one time
Other Names:
|
|
Experimental: High
1.6 mg/kg
|
Intravenously one time
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood pressure
Time Frame: Screening, and 24-hour period after first infusion and after second infusion
|
Screening, and 24-hour period after first infusion and after second infusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Marinobufagenin levels
Time Frame: Screening, and after first and second infusions
|
Screening, and after first and second infusions
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Deepak Malhotra, MD, PhD, University of Toledo
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG0115
- 263-MA-707136-1
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