Hepatorenal SyndromePhase 2NCT06256432
Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome
A Phase 2 study testing Ambrisentan and Terlipressin in people with Hepatorenal Syndrome and Liver Cirrhosis, run by Noorik Biopharmaceuticals AG at 6 sites in India.
Trial summary
Patients with advanced cirrhosis of the liver develop kidney problems occasionally. This condition is called Hepatorenal Syndrome, requires hospitalization and frequently results in death. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatorenal Syndrome, Liver Cirrhosis, Acute Kidney Injury
- What is being tested?
- Ambrisentan and Terlipressin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesIndia
- Study dates
- 17 Apr 2024to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed consent prior to any study-related procedures.
- Age ≥ 18 years and ≤ 70 years.
- Male or non-pregnant, non-lactating female. Women of child-bearing potential must have a confirmed negative serum pregnancy test at the time of screening and must use a highly effective contraceptive method throughout the study such as combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tube occlusion, vasectomised partner, and sexual abstinence and until one month after completing treatment with the study medication. In the case of hormonal contraception, women should have been on a stable regimen for a minimum of three months before study enrolment. Women not of child-bearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy). Men must use an effective contraception method (i.e., condom + diaphragm/spermicidal gel or foam, or vasectomy), and should not donate semen during the study. Men are considered to be fertile from the time of puberty, except for those men with permanent sterility secondary to bilateral orchiectomy.
- Cirrhosis of the liver by laboratory examination, clinical history or biopsy.
- History of ascites.
- Increase in serum creatinine ≥ 0.3 mg/dl (26.5 µmol/L) from a value obtained in the 7 days prior to admission, OR a serum creatinine ≥ 1.5 mg/dl (132.6 µmol/L) and is ≥ 1.5-fold above the most recent and lowest value obtained in the last 3 months.
- The subject has no clinical and/or haemodynamic evidence of intravascular volume depletion; or has undergone at least 12 hours of diuretic withdrawal and fluid resuscitation to discard or treat intravascular volume depletion (such as difficulty in establishing volume status, volume status is assessed as equivocal, or there is clinical and/or haemodynamic evidence of intravascular volume depletion), and no significant improvement in serum creatinine has been observed.
Who cannot join
- Serum creatinine > 5 mg/dL (442 µmol/L).
- Mean arterial pressure (MAP) < 60 mmHg.
- Large Volume Paracentesis (LVP) in the 3 days prior to screening.
- Sepsis, uncontrolled bacterial infection or less than 2 days anti-infective therapy for documented or suspected bacterial infection.
- Total bilirubin > 8 mg/dL (137 µmol/L).
- Serum sodium < 125 mmol/L.
Show all 27Show fewer
- International Normalised Ratio (INR) ≥ 3.5.
- Proteinuria ≥ 1000 mg/dL.
- Microhaematuria > 50 red blood cells per high power field.
- Clinically significant casts on urinalysis, including granular casts.
- History or evidence of obstructive uropathy or parenchymal renal disease on ultrasound or other imaging.
- Subject with a recent history of circulatory shock defined as MAP < 60 mmHg within 5 days prior to screening requiring vasopressors or subjects requires circulatory support with vasopressors during screening.
- Subject requiring oxygen supplementation or mechanical ventilation.
- Recent exposure to nephrotoxic agents or exposure to radiographic contrast agents within 72 hrs prior to screening.
- Superimposed acute liver failure/injury due to factors other than alcohol, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning).
- Severe cardiovascular disease, including, but not limited to, unstable angina, pulmonary oedema, congestive heart failure (NYHA ≥ II), or persisting symptomatic peripheral vascular disease, myocardial infarction or stable chronic angina within the past 12 months, or any other cardiovascular disease judged by the Investigator to be severe.
- Subject has a history of Transjugular Intrahepatic Portosystemic shunt (TIPS).
- Subject with acute variceal bleeding at the time of screening who may undergo pre-emptive TIPS or is anticipated to be treated with terlipressin.
- Current or recent Renal Replacement Therapy (RRT) within 30 days of enrolment, or anticipation of RRT in the next 3 days after screening.
- Hepatocellular Carcinoma (HCC) beyond the Milan criteria or other malignancy affecting survival beyond 6 months.
- Participation in a study of an investigational medical product or device within the last 30 days preceding screening.
- Hepatic Encephalopathy with West Haven Grade III or IV.
- Current or recent (30 days prior to enrolment) treatment with endothelin receptor antagonists, including ambrisentan.
- Estimated life expectancy of less than 3 days.
- Known allergy or sensitivity to ambrisentan or propylene glycol.
- History of Idiopathic Pulmonary Fibrosis.
- Subject is unable or unwilling to follow instructions or comply with study procedures.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Aster CMI Hospital
Bangalore, Karnataka, 560092
Asian Institute of Gastroenterology (AIG)
Hyderabad, Telangana, 500082
Ganesh Shankar Vidyarthi Memorial (GSVM) Medical College
Kanpur, Uttar Pradesh, 208002
Medanta Multi Super Specialty Hospital
Lucknow, Uttar Pradesh, 226030
Sir HN Reliance Hospital Foundation
Mumbai, Maharashtra, 400004
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: A Multi-Centre, Randomised, Open-Label, Phase II Study of Ambrisentan in Patients With Hepatorenal Syndrome
Patients with advanced cirrhosis of the liver develop kidney problems occasionally. This condition is called Hepatorenal Syndrome, requires hospitalization and frequently results in death.
The goal of this clinical trial is to test whether the administration of low doses of ambrisentan can help patients with Hepatorenal Syndrome and to determine if it is safe. Ambrisentan is a drug that is approved for the treatment of high blood pressure in the lungs at higher doses.
Read more
This clinical trial will compare the safety and effects of ambrisentan to another drug called terlipressin, which is commonly used to treat patients with hepatorenal syndrome.
The main questions the clinical trial aims to answer are:
- Does ambrisentan help the kidney function of the patient?
- Does ambrisentan help prevent death in patients with Hepatorenal Syndrome?
- Does ambrisentan prevent Hepatorenal Syndrome from reappearing?
While in the hospital, trial participants will receive either one of two doses of ambrisentan or terlipressin. If in the first 4 days, ambrisentan is not helpful, the patient may be eligible to receive terlipressin. Patients assigned to receive ambrisentan will continue taking this medication at home after leaving the hospitals and until they complete 60 days of treatment.
- Being tested
- Ambrisentan, Terlipressin
- Medical subject headings
- Hepatorenal Syndrome, Liver Cirrhosis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbrisentanDrug
Endothelin receptor antagonist
TerlipressinDrug
Terlipressin
| Study group | Role | What they receive |
|---|---|---|
| Ambrisentan - Low Dose 1 | Experimental | Liquid solution for oral administration, dose < 250 µg/day, up to 60 days Receives: Drug: Ambrisentan |
| Ambrisentan - Low Dose 2 | Experimental | Liquid solution for oral administration, dose < 250 µg/day, up to 60 days Receives: Drug: Ambrisentan |
| Terlipressin | Active comparator | Sterile lyophilized powder, to be reconstituted for intravenous administration, at a dose indicated by the study investigator and administered for up to 14 days, considering the following recommendation: 1 mg terlipressin administered in 2-minute bolus every 6 hours for 3 days, and dose of terlipressin increased to 2 mg every 6 hours in the absence of a decrease of at least 30% in serum creatinine by day 4 Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimated GFR (eGFR) from baseline
As determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
Measured: 4 days
Secondary outcomes (3)
Proportion of patients achieving Hepatorenal Syndrome reversal
Reversal defined as two consecutive serum creatinine values < 1.5 mg/dL (132 µmol/L) within 24 hours
Measured: 14 days
Proportion of subjects experiencing Hepatorenal Syndrome recurrence
Recurrence defined as the appearance of Hepatorenal Syndrome satisfying all clinical trial entry criteria
Measured: 60 days
Overall survival
Proportion of participants alive in each treatment arm
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start17 Apr 2024
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hepatorenal SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noorik Biopharmaceuticals AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iker Navarro, MD, Study director, Noorik Biopharmaceuticals AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256432
- Sponsor's protocol ID
- N-003-CRD005
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Angeli P, Gines P, Wong F, Bernardi M, Boyer TD, Gerbes A, Moreau R, Jalan R, Sarin SK, Piano S, Moore K, Lee SS, Durand F, Salerno F, Caraceni P, Kim WR, Arroyo V, Garcia-Tsao G; International Club of Ascites. Diagnosis and management of acute kidney injury in patients with cirrhosis: revised consensus recommendations of the International Club of Ascites. Gut. 2015 Apr;64(4):531-7. doi: 10.1136/gutjnl-2014-308874. Epub 2015 Jan 28. No abstract available.
PubMed 25631669Soper CP, Latif AB, Bending MR. Amelioration of hepatorenal syndrome with selective endothelin-A antagonist. Lancet. 1996 Jun 29;347(9018):1842-3. No abstract available.
PubMed 8667963Mindikoglu AL, Weir MR. Current concepts in the diagnosis and classification of renal dysfunction in cirrhosis. Am J Nephrol. 2013;38(4):345-54. doi: 10.1159/000355540. Epub 2013 Oct 5.
PubMed 24107793Ring-Larsen H. Renal blood flow in cirrhosis: relation to systemic and portal haemodynamics and liver function. Scand J Clin Lab Invest. 1977 Nov;37(7):635-42. doi: 10.3109/00365517709100657.
PubMed 594643Moore K. Endothelin and vascular function in liver disease. Gut. 2004 Feb;53(2):159-61. doi: 10.1136/gut.2003.024703.
PubMed 14724140Moore K, Wendon J, Frazer M, Karani J, Williams R, Badr K. Plasma endothelin immunoreactivity in liver disease and the hepatorenal syndrome. N Engl J Med. 1992 Dec 17;327(25):1774-8. doi: 10.1056/NEJM199212173272502.
PubMed 1435931Zipprich A, Gittinger F, Winkler M, Dollinger MM, Ripoll C. Effect of ET-A blockade on portal pressure and hepatic arterial perfusion in patients with cirrhosis: A proof of concept study. Liver Int. 2021 Mar;41(3):554-561. doi: 10.1111/liv.14757. Epub 2021 Jan 5.
PubMed 33295121Dhaun N, Macintyre IM, Melville V, Lilitkarntakul P, Johnston NR, Goddard J, Webb DJ. Blood pressure-independent reduction in proteinuria and arterial stiffness after acute endothelin-a receptor antagonism in chronic kidney disease. Hypertension. 2009 Jul;54(1):113-9. doi: 10.1161/HYPERTENSIONAHA.109.132670. Epub 2009 Jun 8.
PubMed 19506099Wong F, Moore K, Dingemanse J, Jalan R. Lack of renal improvement with nonselective endothelin antagonism with tezosentan in type 2 hepatorenal syndrome. Hepatology. 2008 Jan;47(1):160-8. doi: 10.1002/hep.21940.
PubMed 17886336
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Randomised, Open-Label, Phase II Study of Ambrisentan in Patients With Hepatorenal Syndrome
- ClinicalTrials.gov ID
- NCT06256432
- Acronym / sponsor ID
- N-003-CRD005
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Noorik Biopharmaceuticals AGIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Feb 2024 (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.
Patients with advanced cirrhosis of the liver develop kidney problems occasionally. This condition is called Hepatorenal Syndrome, requires hospitalization and frequently results in death.
The goal of this clinical trial is to test whether the administration of low doses of ambrisentan can help patients with Hepatorenal Syndrome and to determine if it is safe. Ambrisentan is a drug that is approved for the treatment of high blood pressure in the lungs at higher doses.
This clinical trial will compare the safety and effects of ambrisentan to another drug called terlipressin, which is commonly used to treat patients with hepatorenal syndrome.
The main questions the clinical trial aims to answer are:
- Does ambrisentan help the kidney function of the patient?
- Does ambrisentan help prevent death in patients with Hepatorenal Syndrome?
- Does ambrisentan prevent Hepatorenal Syndrome from reappearing?
While in the hospital, trial participants will receive either one of two doses of ambrisentan or terlipressin. If in the first 4 days, ambrisentan is not helpful, the patient may be eligible to receive terlipressin. Patients assigned to receive ambrisentan will continue taking this medication at home after leaving the hospitals and until they complete 60 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ambrisentan - Low Dose 1 | Experimental | Drug: AmbrisentanLiquid solution for oral administration, dose < 250 µg/day, up to 60 days |
| Ambrisentan - Low Dose 2 | Experimental | Drug: AmbrisentanLiquid solution for oral administration, dose < 250 µg/day, up to 60 days |
| Terlipressin | Active comparator | Drug: TerlipressinSterile lyophilized powder, to be reconstituted for intravenous administration, at a dose indicated by the study investigator and administered for up to 14 days, considering the following recommendation: 1 mg terlipressin administered in 2-minute bolus every 6 hours for 3 days, and dose of terlipressin increased to 2 mg every 6 hours in the absence of a decrease of at least 30% in serum creatinine by day 4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written Informed consent prior to any study-related procedures.
- Age ≥ 18 years and ≤ 70 years.
- Male or non-pregnant, non-lactating female. Women of child-bearing potential must have a confirmed negative serum pregnancy test at the time of screening and must use a highly effective contraceptive method throughout the study such as combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tube occlusion, vasectomised partner, and sexual abstinence and until one month after completing treatment with the study medication. In the case of hormonal contraception, women should have been on a stable regimen for a minimum of three months before study enrolment. Women not of child-bearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy). Men must use an effective contraception method (i.e., condom + diaphragm/spermicidal gel or foam, or vasectomy), and should not donate semen during the study. Men are considered to be fertile from the time of puberty, except for those men with permanent sterility secondary to bilateral orchiectomy.
- Cirrhosis of the liver by laboratory examination, clinical history or biopsy.
- History of ascites.
Key exclusion criteria (27 listed)
- Serum creatinine > 5 mg/dL (442 µmol/L).
- Mean arterial pressure (MAP) < 60 mmHg.
- Large Volume Paracentesis (LVP) in the 3 days prior to screening.
- Sepsis, uncontrolled bacterial infection or less than 2 days anti-infective therapy for documented or suspected bacterial infection.
- Total bilirubin > 8 mg/dL (137 µmol/L).
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 |
|---|---|---|
| AmbrisentanEndothelin receptor antagonist | Drug | Ambrisentan - Low Dose 1, Ambrisentan - Low Dose 2 |
| TerlipressinTerlipressin | Drug | Terlipressin |
Primary outcome
Change in estimated GFR (eGFR) from baseline
Time frame: 4 days
As determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
3 secondary outcomes
Proportion of patients achieving Hepatorenal Syndrome reversal
Time frame: 14 days
Proportion of subjects experiencing Hepatorenal Syndrome recurrence
Time frame: 60 days
Overall survival
Time frame: 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 25631669Angeli P, Gines P, Wong F, Bernardi M, Boyer TD, Gerbes A, Moreau R, Jalan R, Sarin SK, Piano S, Moore K, Lee SS, Durand F, Salerno F, Caraceni P, Kim WR, Arroyo V, Garcia-Tsao G; International Club of Ascites. Diagnosis and management of acute kidney injury in patients with cirrhosis: revised consensus recommendations of the International Club of Ascites. Gut. 2015 Apr;64(4):531-7. doi: 10.1136/gutjnl-2014-308874. Epub 2015 Jan 28. No abstract available.
- Background: PubMed 8667963Soper CP, Latif AB, Bending MR. Amelioration of hepatorenal syndrome with selective endothelin-A antagonist. Lancet. 1996 Jun 29;347(9018):1842-3. No abstract available.
- Background: PubMed 24107793Mindikoglu AL, Weir MR. Current concepts in the diagnosis and classification of renal dysfunction in cirrhosis. Am J Nephrol. 2013;38(4):345-54. doi: 10.1159/000355540. Epub 2013 Oct 5.
- Background: PubMed 594643Ring-Larsen H. Renal blood flow in cirrhosis: relation to systemic and portal haemodynamics and liver function. Scand J Clin Lab Invest. 1977 Nov;37(7):635-42. doi: 10.3109/00365517709100657.
- Background: PubMed 14724140Moore K. Endothelin and vascular function in liver disease. Gut. 2004 Feb;53(2):159-61. doi: 10.1136/gut.2003.024703.
- Background: PubMed 1435931Moore K, Wendon J, Frazer M, Karani J, Williams R, Badr K. Plasma endothelin immunoreactivity in liver disease and the hepatorenal syndrome. N Engl J Med. 1992 Dec 17;327(25):1774-8. doi: 10.1056/NEJM199212173272502.
- Background: PubMed 33295121Zipprich A, Gittinger F, Winkler M, Dollinger MM, Ripoll C. Effect of ET-A blockade on portal pressure and hepatic arterial perfusion in patients with cirrhosis: A proof of concept study. Liver Int. 2021 Mar;41(3):554-561. doi: 10.1111/liv.14757. Epub 2021 Jan 5.
- Background: PubMed 19506099Dhaun N, Macintyre IM, Melville V, Lilitkarntakul P, Johnston NR, Goddard J, Webb DJ. Blood pressure-independent reduction in proteinuria and arterial stiffness after acute endothelin-a receptor antagonism in chronic kidney disease. Hypertension. 2009 Jul;54(1):113-9. doi: 10.1161/HYPERTENSIONAHA.109.132670. Epub 2009 Jun 8.
- Background: PubMed 17886336Wong F, Moore K, Dingemanse J, Jalan R. Lack of renal improvement with nonselective endothelin antagonism with tezosentan in type 2 hepatorenal syndrome. Hepatology. 2008 Jan;47(1):160-8. doi: 10.1002/hep.21940.
- Individual participant dataSharing planned: Undecided
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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.
Iker Navarro, MD study director
Noorik Biopharmaceuticals AG
6 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 and Terlipressin in people with Hepatorenal Syndrome and Liver Cirrhosis, run by Noorik Biopharmaceuticals AG at 6 sites in India.
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 27 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in estimated GFR (eGFR) from baseline (time frame: 4 days). 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 NCT06256432, which also lists 9 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 13 Apr 2026.