VasculitisNCT02062346
Endothelin Antagonism in ANCA Vasculitis
A study testing BQ123 and BQ123/788 in people with Vasculitis, run by University of Edinburgh at 2 sites in United Kingdom.
Trial summary
Patients with vasculitis commonly develop cardiovascular disease. The reasons for this are not clear and is not adequately treated with current drugs. It is thus understand the reasons why patients with vasculitis develop cardiovascular disease in order to develop new drugs to reduced this risk. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasculitis
- What is being tested?
- BQ123 and BQ123/788
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2016to 1 Jan 2020
- Phase
- Interventional
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18 years and over
- Body mass index ≤35
- Normal serum albumin
Who cannot join
- Subject with diabetes or current smoking or chronic kidney disease (eGFR <60ml/min)
- Subject with pre-existing cardiovascular disease
- Subject is below the age of legal consent, or is mentally or legally incapacitated
- History of multiple and/or severe allergic reactions to drugs (including study drugs)
- The subject has donated blood (450 ml) within the last 4 weeks
- Past or present drug or alcohol abuse including intravenous drug abuse at any time
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- Participation in another clinical trial within 1 month
- Considered to be at high risk of HIV or hepatitis B
- Women of child-bearing potential (only women who are post-menopausal or surgically-sterilised will be included in the study)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Edinburgh
Edinburgh, Midlothian, EH16 4TJ
University of Edinburgh
Edinburgh
About this study
Official title: The Vascular Effects of Endothelin Receptor Antagonism in Systemic Vasculitis
Patients with vasculitis commonly develop cardiovascular disease. The reasons for this are not clear and is not adequately treated with current drugs. It is thus understand the reasons why patients with vasculitis develop cardiovascular disease in order to develop new drugs to reduced this risk.
Endothelin is a chemical produced by blood vessels that contributes to the development of hypertension and cardiovascular disease Higher than normal levels of endothelin are seen in patients with vasculitis but how this contributes to cardiovascular disease in patients with vasculitis is not clear. By using drugs that block the effects of endothelin ('endothelin receptor antagonists') the investigators can hopefully reduce the risk of cardiovascular disease in patients with vasculitis. The purpose of the study is to ascertain if endothelin receptor antagonists improve blood vessel function in patients with vasculitis.
Read the detailed description
Vasculitis patients and healthy controls matched for age, sex will be enrolled into the study. Patients will attend for 4 study days >1 week apart, whereas controls will attend for single day. Circulating Mφ and other immune cells will be confirmed using FACS prior each study.
Study 1 Both patients and control will attend for visit 1: assessment of vascular function using forearm plethysmography as part of case control study.
Vasculitis patients will then attend for visits 2, 3 \& 4 as part of randomised three way crossover study (randomised \& infusions given in a double-blind method): comparison of the effects of selective ETA receptor antagonism (BQ123; 1000nmol/min for 15min iv), mixed ETA/B antagonism (BQ123/788; 1000 nmol/min \& 300 nmol/min for 15 min), and placebo on systemic haemodynamics.
- Conditions
- Vasculitis
- Being tested
- BQ123, BQ123/788, Placebo
- Keywords
- endothelin;, blood pressure;, vasculitis
- Medical subject headings
- Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BQ123Drug
Also called Selective ETA antagonism
Intravenous infusion of BQ123 ( selective ETA antagonist )
BQ123/788Drug
Also called mixed ETA/B antagonism
or BQ123/788 (mixed ETA/B antagonists)
PlaceboDrug
Also called Saline
Intravenous infusion of saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline placebo Receives: Drug: Placebo |
| BQ123 | Experimental | Intravenous infusion of BQ123 1000nmol/min for 15min Receives: Drug: BQ123 |
| BQ123/788 | Experimental | Intravenous infusion of BQ123 1000nmol/min and BQ788 300nmol/min Receives: Drug: BQ123/788 |
| Assessment of forearm vascular function | No intervention | Response of forearm blood flow to endothelium-dependent and endothelium-independent vasodilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1 - forearm blood flow
Response to endothelium-dependent vasodilators
Measured: 20mins
Study 2 - pulse wave velocity
Response of participants to ET antagonism
Measured: 4 hours
Secondary outcomes (3)
Study 1 - tPA release
Response of fibrinolytic system to endothelial vasodilators
Measured: 20min
Study 1 - baseline pulse wave velocity
Baseline arterial stiffness
Measured: Baseline
Study 2 - tPA release
Response of participants to ET antagonism
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startAug 2016
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VasculitisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Neeraj Dhaun, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062346
- Sponsor's protocol ID
- Bean ICRF clinical study
- Status last verified
- Nov 2023
- First submitted
- 11 Feb 2014
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Farrah TE, Melville V, Czopek A, Fok H, Bruce L, Mills NL, Bailey MA, Webb DJ, Dear JW, Dhaun N. Arterial stiffness, endothelial dysfunction and impaired fibrinolysis are pathogenic mechanisms contributing to cardiovascular risk in ANCA-associated vasculitis. Kidney Int. 2022 Nov;102(5):1115-1126. doi: 10.1016/j.kint.2022.07.026. Epub 2022 Aug 20.
PubMed 35998848
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vascular Effects of Endothelin Receptor Antagonism in Systemic Vasculitis
- ClinicalTrials.gov ID
- NCT02062346
- Acronym / sponsor ID
- Bean ICRF clinical study
- Conditions
- Vasculitis
- Keywords
- endothelin;, blood pressure;, vasculitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Aug 2016
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 13 Feb 2014 (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.
Patients with vasculitis commonly develop cardiovascular disease. The reasons for this are not clear and is not adequately treated with current drugs. It is thus understand the reasons why patients with vasculitis develop cardiovascular disease in order to develop new drugs to reduced this risk.
Endothelin is a chemical produced by blood vessels that contributes to the development of hypertension and cardiovascular disease Higher than normal levels of endothelin are seen in patients with vasculitis but how this contributes to cardiovascular disease in patients with vasculitis is not clear. By using drugs that block the effects of endothelin ('endothelin receptor antagonists') the investigators can hopefully reduce the risk of cardiovascular disease in patients with vasculitis. The purpose of the study is to ascertain if endothelin receptor antagonists improve blood vessel function in patients with vasculitis.
Detailed description
Vasculitis patients and healthy controls matched for age, sex will be enrolled into the study. Patients will attend for 4 study days >1 week apart, whereas controls will attend for single day. Circulating Mφ and other immune cells will be confirmed using FACS prior each study.
Study 1 Both patients and control will attend for visit 1: assessment of vascular function using forearm plethysmography as part of case control study.
Vasculitis patients will then attend for visits 2, 3 \& 4 as part of randomised three way crossover study (randomised \& infusions given in a double-blind method): comparison of the effects of selective ETA receptor antagonism (BQ123; 1000nmol/min for 15min iv), mixed ETA/B antagonism (BQ123/788; 1000 nmol/min \& 300 nmol/min for 15 min), and placebo on systemic haemodynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSaline placebo |
| BQ123 | Experimental | Drug: BQ123Intravenous infusion of BQ123 1000nmol/min for 15min |
| BQ123/788 | Experimental | Drug: BQ123/788Intravenous infusion of BQ123 1000nmol/min and BQ788 300nmol/min |
| Assessment of forearm vascular function | No intervention | –Response of forearm blood flow to endothelium-dependent and endothelium-independent vasodilators |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female
- Age 18 years and over
- Body mass index ≤35
- Normal serum albumin
Key exclusion criteria (9 listed)
- Subject with diabetes or current smoking or chronic kidney disease (eGFR <60ml/min)
- Subject with pre-existing cardiovascular disease
- Subject is below the age of legal consent, or is mentally or legally incapacitated
- History of multiple and/or severe allergic reactions to drugs (including study drugs)
- The subject has donated blood (450 ml) within the last 4 weeks
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 |
|---|---|---|
| BQ123Also: Selective ETA antagonismIntravenous infusion of BQ123 ( selective ETA antagonist ) | Drug | BQ123 |
| BQ123/788Also: mixed ETA/B antagonismor BQ123/788 (mixed ETA/B antagonists) | Drug | BQ123/788 |
| PlaceboAlso: SalineIntravenous infusion of saline | Drug | Placebo |
Primary outcome
Study 1 - forearm blood flow
Time frame: 20mins
Response to endothelium-dependent vasodilators
Study 2 - pulse wave velocity
Time frame: 4 hours
Response of participants to ET antagonism
3 secondary outcomes
Study 1 - tPA release
Time frame: 20min
Study 1 - baseline pulse wave velocity
Time frame: Baseline
Study 2 - tPA release
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 35998848Farrah TE, Melville V, Czopek A, Fok H, Bruce L, Mills NL, Bailey MA, Webb DJ, Dear JW, Dhaun N. Arterial stiffness, endothelial dysfunction and impaired fibrinolysis are pathogenic mechanisms contributing to cardiovascular risk in ANCA-associated vasculitis. Kidney Int. 2022 Nov;102(5):1115-1126. doi: 10.1016/j.kint.2022.07.026. Epub 2022 Aug 20.
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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.
Neeraj Dhaun principal investigator
University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BQ123 and BQ123/788 in people with Vasculitis, run by University of Edinburgh at 2 sites in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study 1 - forearm blood flow (time frame: 20mins). The study lists 2 primary outcomes in all. 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 NCT02062346, which also lists 1 linked publication.
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 29 Nov 2023.