HypertensionPhase 4NCT00852787
Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease
A Phase 4 study testing Digoxin immune fab in people with Hypertension and Hemodialysis, run by National Institute on Aging (NIA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Hemodialysis
- What is being tested?
- Digoxin immune fab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo Medical Center
Toledo, Ohio, 43614
About this study
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.
Read the 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.
- Conditions
- Hypertension, Hemodialysis
- Being tested
- Digoxin immune fab, Placebo
- Keywords
- Digoxin like substances, digibind, digoxin immune fab, end-stage-renal-disease, marinobufagenin
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digoxin immune fabDrug
Also called Digibind
Intravenously one time
PlaceboDrug
Intravenously one time
| Study group | Role | What they receive |
|---|---|---|
| Low | Experimental | 0.1mg/kg Receives: Drug: Digoxin immune fab |
| Medium | Experimental | 0.4mg/kg Receives: Drug: Digoxin immune fab |
| High | Experimental | 1.6 mg/kg Receives: Drug: Digoxin immune fab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: Screening, and 24-hour period after first infusion and after second infusion
Secondary outcomes (1)
Marinobufagenin levels
Measured: Screening, and after first and second infusions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Toledo Health Science Campus
- Investigators
- Deepak Malhotra, MD, PhD, Principal investigator, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852787
- Sponsor's protocol ID
- AG0115
- Other IDs
- 263-MA-707136-1
- Status last verified
- Dec 2009
- First submitted
- 26 Feb 2009
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18542120Mohmand 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.
PubMed 15970476Fedorova 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.
PubMed 19008721
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT00852787
- Acronym / sponsor ID
- AG0115
- Conditions
- Hypertension, Hemodialysis
- Keywords
- Digoxin like substances, digibind, digoxin immune fab, end-stage-renal-disease, marinobufagenin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- University of Toledo Health Science Campus
- Study start
- Apr 2009
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low | Experimental | Drug: Digoxin immune fab0.1mg/kg |
| Medium | Experimental | Drug: Digoxin immune fab0.4mg/kg |
| High | Experimental | Drug: Digoxin immune fab1.6 mg/kg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digoxin immune fabAlso: DigibindIntravenously one time | Drug | High, Low, Medium |
| PlaceboIntravenously one time | Drug | Placebo |
Primary outcome
Blood pressure
Time frame: Screening, and 24-hour period after first infusion and after second infusion
1 secondary outcome
Marinobufagenin levels
Time frame: Screening, and after first and second infusions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
- Background: PubMed 18542120Bagrov 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.
- Background: PubMed 15970476Mohmand 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.
- Background: PubMed 19008721Fedorova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak Malhotra, MD, PhD principal investigator
University of Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Digoxin immune fab in people with Hypertension and Hemodialysis, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Screening, and 24-hour period after first infusion and after second infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00852787, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2012.