MEMBRANOUS NEPHROPATHYPhase 3STARMENNCT01955187

Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous Nephropathy

A Phase 3 study testing TACROLIMUS, RITUXIMAB and METHYLPREDNISOLONE in people with MEMBRANOUS NEPHROPATHY, run by Hospital Universitario 12 de Octubre at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In this study, investigators will evaluated the long-term efficacy and safety (two years) of Tacrolimus-Rituximab (RTX) therapy compared to Methylprednisolone-Cyclophosphamide (CYC) therapy in patients with primary Membranous Nephropathy (MN). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: MEMBRANOUS NEPHROPATHY
What is being tested?: TACROLIMUS, RITUXIMAB and METHYLPREDNISOLONE
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 1 siteSpain
Study dates: Jan 2014to 26 Jun 2019
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients are willing and able to read and correctly understand the patient's information sheet and give their consent for participation in the study (by correctly signing and dating the informed consent form document, which has been previously approved by an Ethics Committee/ International Review Board), before initiating any protocol specific selection procedure.
Patients are able to understand study procedures and to comply with them for the entire length of the study.
Age older than 18 years.
Biopsy-proven primary MN. Patients with nephrotic syndrome relapse after remission (either spontaneous or induced by immunosuppression) can be included without a new renal biopsy, provided that they meet all the other inclusion/exclusion criteria.
Estimated GFR ≥ 45 ml/min/1.73m2 in one measurement performed within the screening period (in the 30 days after informed consent signature).
Nephrotic-range proteinuria (>4 g/day and not decreasing >50% in the last 6 months) accompanied by hypoalbuminemia ≤ 3, 5 g/dL during the screening period OR patients showing severe or disabling symptoms related to the nephrotic syndrome or severe hypoalbuminemia (<2 g/dL), that can be included before the completion of this 6-month observation period, at the investigator's discretion, independently of proteinuria values.
Treatment with an ACEI or ARB for at least 2 months before screening (unless intolerance to ACEI/ARB, contraindications to their use or a low blood pressure that could induce side effects at the investigator's discretion) with a controlled blood pressure for at least the last three months (Mean SBP/DBP ≤ 150/90 mmHg in the last three months).
Negative urine pregnancy test for potentially fertile female.

Who cannot join

Diagnosis of secondary causes of membranous nephropathy: malignancy (cancer), systemic infections (which include B and C hepatitis), systemic autoimmune diseases (e.g. Systemic Lupus Erythematosus; SLE) or any other acute or chronic inflammatory disease.
HIV infection.
Moderate or severe liver disease (AST and ALT > 2.5x upper range limit and total bilirubin > 1.5 x upper range limit).
Patients are taking part in any other study with an investigational study and/or are receiving or have received treatment with another investigational drug or intervention (within the first month prior to the signature of the informed consent).
Suspected or known hypersensitivity, allergy and/or immunogenic reaction history to either rituximab, cyclosporine, tacrolimus, corticosteroids, CYC or any of their ingredients (which include excipients) and of any other drug from the same pharmacotherapeutic group (i.e. calcineurin inhibitors, specific monoclonal antibodies or alkylating agents).
Previous treatment with corticosteroids in the three months period before screening, or previous treatment with other immunosuppressive agent in the six month period before screening.

Show all 12Show fewer

Previous treatment with rituximab or any other biological agent in the two years period before screening.
Patients who were non-responders to previous immunosuppressants.
Women with a positive pregnancy test at screening or in lactation period or planning to become pregnant within the next 24 months. Women not willing to use contraceptive methods during the complete study period.
Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Any other medical unstable, uncontrolled, or severe condition or any other relevant laboratory test finding which, at the investigator's own discretion, could possibly increase the associated risk of the patient's participation in the study.
Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital 12 de Octubre
Madrid

Other trials in Spain

About this study

Official title: European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study)

PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus leads to a greater increase in the proportion of primary MN patients with Complete or Partial Remission when compared with patients receiving standard treatment. It will be assessed 24 months after the beginning of treatment.

Phase of the trial: and design: Phase III study, open label, randomized, and active controlled trial.

This study will have 3 stages: screening and recruitment of patients for 18 months, treatment period for six months in corticosteroids plus CYC group and 9 months in Tacrolimus-RTX group, and finally post-treatment follow-up period until to complete 24 months of follow-up since initial treatment.

This study will compare the standard therapy for primary MN patients with nephrotic range proteinuria (active control of steroids plus CYC) with a novel sequential therapy of tacrolimus and RTX, an approach of potential high efficacy, low toxicity and more acceptable safety profile.

Read the detailed description

PRIMARY AND SECONDARY ENDPOINTS/OUTCOME MEASURES

Primary end-point:

The proportion of patients reaching CR defined as a reduction of proteinuria since baseline level to a value equal or lower than 0.5 g/24 h proteinuria plus stable renal function (eGFR ≥ 45 ml/min/1.73m2) or PR defined as a reduction of proteinuria since baseline level to a value less than 3.5 g/24 h and 50% lower than baseline proteinuria plus stable renal function (eGFR ≥ 45ml/min/1.73m2) at 24 months of study treatment.

Secondary end-points

The proportion of patients with Limited response (LR) defined as a reduction of proteinuria since baseline level > 50% but to a value > 3.5g/24 h. at 12, 18 and 24 months of study treatment..
The number of patients with an increase ≥ 50% of serum creatinine (SCr) from baseline at 12, 18 and 24 months (end of the follow-up).
The time of renal survival (status free of increase ≥ 50% of baseline SCr) in both arms overall after the study.
The proportion of patients with preserved renal function (estimated GFR ≥ 60 ml/min) in both treatment arms after the treatment period.
The proportion of patients with relapse (defines as the reappearance of proteinuria > 3.5 gr/24h and at least 50% increase over the lowest baseline value in at least three consecutive visits in those patients who previously presented a PR or CR) and the time to relapse after the treatment period.
Serum levels of anti-phospholipase A2 receptor antibodies (anti-PLA2R), before of treatment and at 3, 6, 9, 12, 18 and 24 months of study, in both treatment arms.
The proportion of patient with drug-related adverse events and serious adverse events.

STUDY POPULATION

Patients with biopsy-proven idiopathic or primary membranous nephropathy with nephrotic proteinuria and normal or slight decrease of renal function will be enrolled.

Conditions: MEMBRANOUS NEPHROPATHY
Being tested: TACROLIMUS, RITUXIMAB, METHYLPREDNISOLONE, CYCLOPHOSPHAMIDE
Keywords: SEQUENTIAL THERAPY, PRIMARY MEMBRANOUS NEPHROPATHY, TACROLIMUS, RITUXIMAB
Medical subject headings: Glomerulonephritis, Membranous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TACROLIMUSDrug
Also called TACROLIMUS, ADVAGRAF
Initial dose: 0.05 mg/Kg/day, adjusted to achieve blood trough levels of 5-7 ng/ml) for six months. Starting at the end of month 6, tacrolimus dosage will be reduced by 25% per month, resulting in a complete withdrawal at the end of month 9.
RITUXIMABDrug
Also called RITUXIMAB, MABTHERA
A dose 1 g IV will be given during month 6 (at day 180), before the onset of tacrolimus dose reduction
METHYLPREDNISOLONEDrug
Also called METHYLPREDNISOLONE, URBASON, SOLUMODERIN
Month 1: 1g IV methylprednisolone daily for three doses (days 1, 2, and 3), Oral methylprednisolone (0.5mg/kg/day) for 27 days (days 4 to 30). Months 3, and 5: Repeat Month 1.
CYCLOPHOSPHAMIDEDrug
Also called CYCLOPHOSPHAMIDE, GENOXAL
Month 2: Oral Cyclophosphamide (2.0 mg/kg/day) for 30 days. Months 4, and 6: Repeat month 2.

Study groups in NCT01955187
Study group	Role	What they receive
Sequential therapy: Tacrolimus-Rituximab	Experimental	Tacrolimus: Initial dose of 0.05 mg/Kg/day PO, adjusted to blood levels (5- 7 ng/ml) for six months. Starting at the end of month 6, tacrolimus will be reduced by 25% per month, resulting in a complete withdrawal at the end of month 9. Receives: Drug: TACROLIMUS; Drug: RITUXIMAB
Cyclical therapy: Corticosteroids and Cyclophosphamide	Active comparator	Month 1, 3 and 5: 1g IV methylprednisolone daily for three doses, oral methylprednisolone (0.5mg/kg/day) Month 2, 4 and 6: Oral Cyclophosphamide (2.0 mg/kg/day) Receives: Drug: METHYLPREDNISOLONE; Drug: CYCLOPHOSPHAMIDE

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients with complete and/or partial remission.
The proportion of patients reaching complete remission, defined as a reduction of proteinuria since baseline level to a value equal or lower than 0.5 g/24 h proteinuria plus stable renal function (eGFR ≥ 45 ml/min/1.73m2) or partial remission, defined as a reduction of proteinuria since baseline level to a value less than 3.5 g/24 h and 50% lower than baseline proteinuria plus stable renal function (eGFR ≥ 45 ml/min/1.73m2) at 24 months of study treatment.
Measured: 24 months

Secondary outcomes (4)

Proportion of patients with limited response
The proportion of patients with limited response, defined as a reduction of proteinuria since baseline level > 50% but to a value > 3.5g/24 h. at 12, 18 and 24 months of study treatment.
Measured: 12, 18, and 24 months
Proportion of patients with increase of baseline serum creatinine ≥ 50%
The number of patients with an increase ≥ 50% of serum creatinine (SCr) from baseline at 12, 18 and 24 months (end of the follow-up).
Measured: 12, 18, and 24 months
Proportions of patients with relapses
The proportion of patients with relapses (defines as the reappearance of proteinuria > 3.5 gr/24h and at least 50% increase over the lowest baseline value in at least three consecutive visits in those patients who previously presented a PR or CR) and the time to relapse after the treatment period.
Measured: 9, 12, 18, and 24 months
Proportion of patients with drug-related adverse events
The proportion of patient with drug-related adverse events and serious adverse events.
Measured: During all therapy period and until 24 months post-beginning of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201426 Jun 2019

First posted7 Oct 2013 (estimated)
Study startJan 2014
Primary completion26 Jun 2019
Study completion26 Jun 2019

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 MEMBRANOUS NEPHROPATHYStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01955187
Sponsor's protocol ID: STARMEN 01-2013
Other IDs: 2013-000226-55
Acronym: STARMEN
Status last verified: Jan 2020
First submitted: 19 Sep 2013
Last updated: 18 Jan 2020
Results posted: No
Data monitoring committee: Yes

Publications

von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
PubMed 34778952

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All MEMBRANOUS NEPHROPATHY trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study)
ClinicalTrials.gov ID: NCT01955187
Acronym / sponsor ID: STARMEN / STARMEN 01-2013
Conditions: MEMBRANOUS NEPHROPATHY
Keywords: SEQUENTIAL THERAPY, PRIMARY MEMBRANOUS NEPHROPATHY, TACROLIMUS, RITUXIMAB
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Hospital Universitario 12 de OctubreUniversity, hospital or other
Collaborators: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital Universitario Fundación Alcorcón, Biobanco REDinREN, ERA-EDTA, REDinREN, Spanish Society of Nephrology, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, University Hospital, Aachen
Study start: Jan 2014 (actual)
Primary completion: 26 Jun 2019 (actual)
Study completion: 26 Jun 2019 (actual)
First posted: 7 Oct 2013 (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.

Phase of the trial: and design: Phase III study, open label, randomized, and active controlled trial.

Detailed description

PRIMARY AND SECONDARY ENDPOINTS/OUTCOME MEASURES

Primary end-point:

Secondary end-points

The proportion of patients with Limited response (LR) defined as a reduction of proteinuria since baseline level > 50% but to a value > 3.5g/24 h. at 12, 18 and 24 months of study treatment..
The number of patients with an increase ≥ 50% of serum creatinine (SCr) from baseline at 12, 18 and 24 months (end of the follow-up).
The time of renal survival (status free of increase ≥ 50% of baseline SCr) in both arms overall after the study.
The proportion of patients with preserved renal function (estimated GFR ≥ 60 ml/min) in both treatment arms after the treatment period.
The proportion of patients with relapse (defines as the reappearance of proteinuria > 3.5 gr/24h and at least 50% increase over the lowest baseline value in at least three consecutive visits in those patients who previously presented a PR or CR) and the time to relapse after the treatment period.
Serum levels of anti-phospholipase A2 receptor antibodies (anti-PLA2R), before of treatment and at 3, 6, 9, 12, 18 and 24 months of study, in both treatment arms.
The proportion of patient with drug-related adverse events and serious adverse events.

STUDY POPULATION

Patients with biopsy-proven idiopathic or primary membranous nephropathy with nephrotic proteinuria and normal or slight decrease of renal function will be enrolled.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequential therapy: Tacrolimus-Rituximab	Experimental	Drug: TACROLIMUS, Drug: RITUXIMABTacrolimus: Initial dose of 0.05 mg/Kg/day PO, adjusted to blood levels (5- 7 ng/ml) for six months. Starting at the end of month 6, tacrolimus will be reduced by 25% per month, resulting in a complete withdrawal at the end of month 9.
Cyclical therapy: Corticosteroids and Cyclophosphamide	Active comparator	Drug: METHYLPREDNISOLONE, Drug: CYCLOPHOSPHAMIDEMonth 1, 3 and 5: 1g IV methylprednisolone daily for three doses, oral methylprednisolone (0.5mg/kg/day) Month 2, 4 and 6: Oral Cyclophosphamide (2.0 mg/kg/day)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients are willing and able to read and correctly understand the patient's information sheet and give their consent for participation in the study (by correctly signing and dating the informed consent form document, which has been previously approved by an Ethics Committee/ International Review Board), before initiating any protocol specific selection procedure.
Patients are able to understand study procedures and to comply with them for the entire length of the study.
Age older than 18 years.
Biopsy-proven primary MN. Patients with nephrotic syndrome relapse after remission (either spontaneous or induced by immunosuppression) can be included without a new renal biopsy, provided that they meet all the other inclusion/exclusion criteria.
Estimated GFR ≥ 45 ml/min/1.73m2 in one measurement performed within the screening period (in the 30 days after informed consent signature).

Key exclusion criteria (12 listed)

Diagnosis of secondary causes of membranous nephropathy: malignancy (cancer), systemic infections (which include B and C hepatitis), systemic autoimmune diseases (e.g. Systemic Lupus Erythematosus; SLE) or any other acute or chronic inflammatory disease.
HIV infection.
Moderate or severe liver disease (AST and ALT > 2.5x upper range limit and total bilirubin > 1.5 x upper range limit).
Patients are taking part in any other study with an investigational study and/or are receiving or have received treatment with another investigational drug or intervention (within the first month prior to the signature of the informed consent).
Suspected or known hypersensitivity, allergy and/or immunogenic reaction history to either rituximab, cyclosporine, tacrolimus, corticosteroids, CYC or any of their ingredients (which include excipients) and of any other drug from the same pharmacotherapeutic group (i.e. calcineurin inhibitors, specific monoclonal antibodies or alkylating agents).

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
TACROLIMUSAlso: TACROLIMUS, ADVAGRAFInitial dose: 0.05 mg/Kg/day, adjusted to achieve blood trough levels of 5-7 ng/ml) for six months. Starting at the end of month 6, tacrolimus dosage will be reduced by 25% per month, resulting in a complete withdrawal at the end of month 9.	Drug	Sequential therapy: Tacrolimus-Rituximab
RITUXIMABAlso: RITUXIMAB, MABTHERAA dose 1 g IV will be given during month 6 (at day 180), before the onset of tacrolimus dose reduction	Drug	Sequential therapy: Tacrolimus-Rituximab
METHYLPREDNISOLONEAlso: METHYLPREDNISOLONE, URBASON, SOLUMODERINMonth 1: 1g IV methylprednisolone daily for three doses (days 1, 2, and 3), Oral methylprednisolone (0.5mg/kg/day) for 27 days (days 4 to 30). Months 3, and 5: Repeat Month 1.	Drug	Cyclical therapy: Corticosteroids and Cyclophosphamide
CYCLOPHOSPHAMIDEAlso: CYCLOPHOSPHAMIDE, GENOXALMonth 2: Oral Cyclophosphamide (2.0 mg/kg/day) for 30 days. Months 4, and 6: Repeat month 2.	Drug	Cyclical therapy: Corticosteroids and Cyclophosphamide

Primary outcome

Proportion of patients with complete and/or partial remission.
Time frame: 24 months
The proportion of patients reaching complete remission, defined as a reduction of proteinuria since baseline level to a value equal or lower than 0.5 g/24 h proteinuria plus stable renal function (eGFR ≥ 45 ml/min/1.73m2) or partial remission, defined as a reduction of proteinuria since baseline level to a value less than 3.5 g/24 h and 50% lower than baseline proteinuria plus stable renal function (eGFR ≥ 45 ml/min/1.73m2) at 24 months of study treatment.

4 secondary outcomes

Proportion of patients with limited response
Time frame: 12, 18, and 24 months
Proportion of patients with increase of baseline serum creatinine ≥ 50%
Time frame: 12, 18, and 24 months
Proportions of patients with relapses
Time frame: 9, 12, 18, and 24 months
Proportion of patients with drug-related adverse events
Time frame: During all therapy period and until 24 months post-beginning of therapy

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 18 Jan 2020.
Derived from this study: PubMed 34778952von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

Related trials for MEMBRANOUS NEPHROPATHY

Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingPhase 2/3
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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.

GEMA FERNÁNDEZ-JUÁREZ, MD principal investigator

Hospital Universitario Fundación Alcorcón, Madrid. Spain

JESUS EGIDO, MD, PhD principal investigator

IIS Fundación Jiménez Díaz, Madrid. Spain

MARIAN GOICOCHEA, MD principal investigator

Hospital Universitario Gregorio Marañón, Madrid. Spain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TACROLIMUS, RITUXIMAB and METHYLPREDNISOLONE in people with MEMBRANOUS NEPHROPATHY, run by Hospital Universitario 12 de Octubre at 1 site in Spain.

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 8 inclusion and 12 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 18 Jan 2020. 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Proportion of patients with complete and/or partial remission. (time frame: 24 months). 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 NCT01955187, 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 18 Jan 2020.