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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension, Hemodialysis

Intervention / Treatment
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* Drug: Digoxin immune fab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low<br>0.1mg/kg | Drug: Digoxin immune fab<br>* Intravenously one time<br>* Other names: Digibind;|
| Experimental: Medium<br>0.4mg/kg | Drug: Digoxin immune fab<br>* Intravenously one time<br>* Other names: Digibind;|
| Experimental: High<br>1.6 mg/kg | Drug: Digoxin immune fab<br>* Intravenously one time<br>* Other names: Digibind;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Intravenously one time<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digoxin like substances, digibind, digoxin immune fab, end-stage-renal-disease, marinobufagenin