Kidney Failure, AcutePhase 2NCT04450095
Effects of Endothelin Receptor Antagonist on Ischemic Kidney Injury During Nephron Sparing Surgery
A Phase 2 study testing Ambrisentan 10 MG in people with Kidney Failure, Acute, run by Bnai Zion Medical Center at 2 sites in Israel.
Trial summary
Based on animal studies, it was found that administration of endothelial receptor antagonists before and after renal blood vessels clamp and release results in a significantly reduced renal function injury. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Failure, Acute
- What is being tested?
- Ambrisentan 10 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- 11 Oct 2018to 1 Oct 2020
- Phase
- Phase 2
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a single kidney lesion who undergo Contrast enhancement (by CT scan)
- Normal contra-lateral kidney as illustrated by imaging tests
- Patients eligible for anesthesia and surgery
Who cannot join
- Patients with chronic kidney infections
- Blood clot disorders
- End-stage renal failure
- Patients sensitive to the study drug
- Patients with cardiac heart failure, EF <40%
- Patients with hyperkalemia
- Patients with systolic blood pressure under 90 mmHg
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Bnai-Zion Medical Center
Haifa, 3339419
Department of Physiology, The Bruce and Ruth Rapapport Faculty of Medicine, Technion
Haifa, 3525408
About this study
Official title: Effects of Endothelin Receptor Antagonist on Ischemic Kidney Injury During Nephron Sparing Surgery for Renal Mass Excision: Assessment by Ischemia Biomarkers, NGAL, KIM-1
Based on animal studies, it was found that administration of endothelial receptor antagonists before and after renal blood vessels clamp and release results in a significantly reduced renal function injury.
On the basis of these results, we chose to divide the study population into 2 groups: control group that would be treated the standard accepted preventive treatment: intravenous injection of Mannitol, cooling of the kidney surface, compared to the treatment group that in addition would receive pre- and post-operative treatment of endothelial receptor antagonists (Ambrisentan (Volibris (10mg).
Read more
To be noticed that the drug is recognized and is given as a primary indication for patients with pulmonary hypertension.
The differences between the renal function and biomarkers for pre- and post-operative renal ischemic injury would be examined in order to disclose if the kidney injury of the treated group was indeed smaller.
This information will enable us to protect the operated kidneys from the ischemic damage, especially in those patients with poor basic renal function.
Read the detailed description
This is a study aimed at examining the protective effect of endothelin antagonism on the ischemic damage the kidney undergoes during partial nephrectomy for kidney lesion removal.
In such procedure, it is common to clamp the kidney blood vessels in order to eliminate blood flow in the surgical field that will enable clear visibility to differentiate the tumor tissue from the normally kidney parenchyma.
Later, after removing the tumor lesion and suturing the tumor bed, the blockage is released and the renal blood flow returns.
The blockage itself and its release causes damage to the kidney tissue that is usually reduced by the kidney's cooling (through ice crystals)and as well as intravenous injection of mannitol.
In this study, patients were divided into 2 groups randomly, assigned the receipt in the order of recruitment.
The first group will receive the standard treatment and the other will be given before and after surgery endothelin antagonists in addition to the standard treatment. The drug will be given once a day for 5 days, starting 48 hours before surgery. Treatment efficacy assessment will be based on comparison of renal function (serum creatinine level and glomerular filtration) as well as biomarkers of acute renal damage (NGAL, KIM-1, and others) that will be taken from patients before and at different time points after surgery: urine samples to be taken at the following time points: - 3 , 8,24,48,72 hours after surgery. Blood samples will be taken at the following time points: - 8, 24, 48, 72 hours after surgery.
- Conditions
- Kidney Failure, Acute
- Being tested
- Ambrisentan 10 MG
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambrisentan 10 MGDrug
be given once a day for 5 days, starting 48 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Active comparator | Tab. Volibris 10mg given once a day for 5 days, starting 48 hours before surgery (in addition for the standard treatment for partial nephrectomy) Receives: Drug: Ambrisentan 10 MG |
| Control group | No intervention | Treated with the standard treatment for partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
RENAL FUNCTION INJURY
quantified by serum CRE, KIM-1,NGAL and urine markers KIM-1 NGAL
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start11 Oct 2018
- Primary completion1 Feb 2020
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, AcuteStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Principal investigator, Ofir. Avitan, Bnai Zion Medical Center
- Investigators
- Ofir Avitan, M.D., Principal investigator, Bnai-zion medical center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450095
- Sponsor's protocol ID
- 0048-18-BNZ
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the Patients index and the collected data will be provided without private names or ID numbers
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endothelin Receptor Antagonist on Ischemic Kidney Injury During Nephron Sparing Surgery for Renal Mass Excision: Assessment by Ischemia Biomarkers, NGAL, KIM-1
- ClinicalTrials.gov ID
- NCT04450095
- Acronym / sponsor ID
- 0048-18-BNZ
- Conditions
- Kidney Failure, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Collaborators
- Rambam Health Care Campus
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 29 Jun 2020 (actual)
- 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.
Based on animal studies, it was found that administration of endothelial receptor antagonists before and after renal blood vessels clamp and release results in a significantly reduced renal function injury.
On the basis of these results, we chose to divide the study population into 2 groups: control group that would be treated the standard accepted preventive treatment: intravenous injection of Mannitol, cooling of the kidney surface, compared to the treatment group that in addition would receive pre- and post-operative treatment of endothelial receptor antagonists (Ambrisentan (Volibris (10mg).
To be noticed that the drug is recognized and is given as a primary indication for patients with pulmonary hypertension.
The differences between the renal function and biomarkers for pre- and post-operative renal ischemic injury would be examined in order to disclose if the kidney injury of the treated group was indeed smaller.
This information will enable us to protect the operated kidneys from the ischemic damage, especially in those patients with poor basic renal function.
Detailed description
This is a study aimed at examining the protective effect of endothelin antagonism on the ischemic damage the kidney undergoes during partial nephrectomy for kidney lesion removal.
In such procedure, it is common to clamp the kidney blood vessels in order to eliminate blood flow in the surgical field that will enable clear visibility to differentiate the tumor tissue from the normally kidney parenchyma.
Later, after removing the tumor lesion and suturing the tumor bed, the blockage is released and the renal blood flow returns.
The blockage itself and its release causes damage to the kidney tissue that is usually reduced by the kidney's cooling (through ice crystals)and as well as intravenous injection of mannitol.
In this study, patients were divided into 2 groups randomly, assigned the receipt in the order of recruitment.
The first group will receive the standard treatment and the other will be given before and after surgery endothelin antagonists in addition to the standard treatment. The drug will be given once a day for 5 days, starting 48 hours before surgery. Treatment efficacy assessment will be based on comparison of renal function (serum creatinine level and glomerular filtration) as well as biomarkers of acute renal damage (NGAL, KIM-1, and others) that will be taken from patients before and at different time points after surgery: urine samples to be taken at the following time points: - 3 , 8,24,48,72 hours after surgery. Blood samples will be taken at the following time points: - 8, 24, 48, 72 hours after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | Active comparator | Drug: Ambrisentan 10 MGTab. Volibris 10mg given once a day for 5 days, starting 48 hours before surgery (in addition for the standard treatment for partial nephrectomy) |
| Control group | No intervention | –Treated with the standard treatment for partial nephrectomy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a single kidney lesion who undergo Contrast enhancement (by CT scan)
- Normal contra-lateral kidney as illustrated by imaging tests
- Patients eligible for anesthesia and surgery
Key exclusion criteria (7 listed)
- Patients with chronic kidney infections
- Blood clot disorders
- End-stage renal failure
- Patients sensitive to the study drug
- Patients with cardiac heart failure, EF <40%
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 |
|---|---|---|
| Ambrisentan 10 MGbe given once a day for 5 days, starting 48 hours before surgery | Drug | Treated group |
Primary outcome
RENAL FUNCTION INJURY
Time frame: 2 YEARS
quantified by serum CRE, KIM-1,NGAL and urine markers KIM-1 NGAL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Individual participant dataSharing planned: No. Only the Patients index and the collected data will be provided without private names or ID numbers
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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.
Ofir Avitan, M.D. principal investigator
Bnai-zion medical center, Haifa, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ambrisentan 10 MG in people with Kidney Failure, Acute, run by Bnai Zion Medical Center at 2 sites in Israel.
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 3 inclusion and 7 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 29 Jun 2020. 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 Israel. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
RENAL FUNCTION INJURY (time frame: 2 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2020.