End Stage Renal DiseasePhase 2Xigris1003NCT01227187

Safety and Dose Finding Study of Xigris in Hemodialysis Patients

A Phase 2 study testing Drotrecogin alfa activated (Xigris) in people with End Stage Renal Disease, run by George Washington University at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Disease
What is being tested?: Drotrecogin alfa activated (Xigris)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Oct 2008to Dec 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

>18
Usually used heparin with HD

Who cannot join

Plt <100
Pregnancy
H/o bleeding diathesis
H/o CVA
Pt on Ticlid/plavix/warfarin
SBP >200
BASELINE PTT>50
INR>1.6

Trial locations and contacts

1 site in 1 country.

United States1 site

The George Washington University Hospital
Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: Safety and Dose Finding Study of Xigris (Drotrecogin Alfa Activated) as an Anti-coagulant in End Stage Renal Disease (ESRD) Patients Treated With Hemodialysis (HD)

The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).

Read the detailed description

In United States, there are over 300,000 patients with ESRD who require hemodialysis. Clinical hemodialysis takes place three times a week and is dependent on adequate anticoagulation throughout the three to four hour procedure. Infection is one of the most common causes of death for patients with ESRD treated with hemodialysis (25%).

Xigris (drotrecogin alfa activated) is a recombinant form of human activated protein C and is successfully used for treatment of adult patients with severe sepsis. In addition to its fibrinolytic properties, drotrecogin alpha has both an anti-inflammatory effect, and an anti-coagulant effect. However, there are few safety and no efficacy data on the effect of Xigris in ESRD patients as an anticoagulant.

Conditions: End Stage Renal Disease
Being tested: Drotrecogin alfa activated (Xigris)
Keywords: Hemodialysis, Anticoagulation, Xigris, PTT
Medical subject headings: Kidney Failure, Chronic

What participants receive

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

Drotrecogin alfa activated (Xigris)Drug
Also called Drotrecogin alfa (activated)
We will test different dose regimens of Drotrecogin alfa activated (Xigris) to determine the optimal dose to achieve PTT between 65 and 100 secs. The initial patients will receive Xigris dosed at an infusion rate of 12 mcg/kg/h via pre-filter arterial drip chamber via a standard IV pump. The PTT will be assessed at baseline,15,30,60,120 and 180 mins. Xigris dose will be adjusted in the following patients if the afferent PTT rises above 100 secs (normal range 25-40 secs) or if PTT remains <65 secs. If PTT remains less than 65 secs, the dose will be increased to the second dose regiment of 18 mcg/kg/hr. The dose escalation will continue in increments of 6 mcg/kg/h to a maximum dose of 36 mcg/kg/h. Each patient will receive Xigris only once.

Study groups in NCT01227187
Study group	Role	What they receive
Xigris	Experimental	Drotrecogin alfa activated (Xigris) used as anticoagulant in patients treated with hemodialysis. Receives: Drug: Drotrecogin alfa activated (Xigris)

What is being measured

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

Mean Partial Thromboplastin Time (PTT) at 15 Minutes
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Measured: PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.
Mean Partial Thromboplastin Time (PTT) at 30 Minutes
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Measured: PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment.
Mean Partial Thromboplastin Time (PTT) at 60 Minutes
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Measured: PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment.
Mean Partial Thromboplastin Time (PTT) at 120 Minutes
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Measured: PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment.
Mean Partial Thromboplastin Time (PTT) at 180 Minutes
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Measured: PTT level at 180 minutes after start up of Xigris during the hemodialysis treatment.

Timeline

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

Oct 2008Dec 2010

First posted25 Oct 2010 (estimated)
Study startOct 2008
Primary completionNov 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (21)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by George Washington UniversityThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01227187
Sponsor's protocol ID: F1K-MC-1003
Acronym: Xigris1003
Status last verified: Nov 2020
First submitted: 14 Jul 2010
Last updated: 3 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hakim RM, Held PJ, Stannard DC, Wolfe RA, Port FK, Daugirdas JT, Agodoa L. Effect of the dialysis membrane on mortality of chronic hemodialysis patients. Kidney Int. 1996 Aug;50(2):566-70. doi: 10.1038/ki.1996.350.
PubMed 8840287
Hakim RM, Breyer J, Ismail N, Schulman G. Effects of dose of dialysis on morbidity and mortality. Am J Kidney Dis. 1994 May;23(5):661-9. doi: 10.1016/s0272-6386(12)70276-7.
PubMed 8172208
Held PJ, Port FK, Webb RL, Wolfe RA, Bloembergen WE, Turenne MN, Holzman E, Ojo AO, Young EW, Mauger EA, et al. Excerpts from United States Renal Data System 1995 Annual Data Report. Am J Kidney Dis. 1995 Oct;26(4 Suppl 2):S1-186. No abstract available.
PubMed 7573030
Held PJ, Port FK, Wolfe RA, Stannard DC, Carroll CE, Daugirdas JT, Bloembergen WE, Greer JW, Hakim RM. The dose of hemodialysis and patient mortality. Kidney Int. 1996 Aug;50(2):550-6. doi: 10.1038/ki.1996.348.
PubMed 8840285
Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Cruz I, Veis JH. Psychosocial factors, behavioral compliance and survival in urban hemodialysis patients. Kidney Int. 1998 Jul;54(1):245-54. doi: 10.1046/j.1523-1755.1998.00989.x.
PubMed 9648085
Lowrie EG, Laird NM, Parker TF, Sargent JA. Effect of the hemodialysis prescription on patient morbidity: report from the National Cooperative Dialysis Study. N Engl J Med. 1981 Nov 12;305(20):1176-81. doi: 10.1056/NEJM198111123052003.
PubMed 7027040
Lowrie EG, Lew NL. Death risk in hemodialysis patients: the predictive value of commonly measured variables and an evaluation of death rate differences between facilities. Am J Kidney Dis. 1990 May;15(5):458-82. doi: 10.1016/s0272-6386(12)70364-5.
PubMed 2333868
Owen WF Jr, Lew NL, Liu Y, Lowrie EG, Lazarus JM. The urea reduction ratio and serum albumin concentration as predictors of mortality in patients undergoing hemodialysis. N Engl J Med. 1993 Sep 30;329(14):1001-6. doi: 10.1056/NEJM199309303291404.
PubMed 8366899
Causes of death. USRDS. United States Renal Data System. Am J Kidney Dis. 1997 Aug;30(2 Suppl 1):S107-17. No abstract available.
PubMed 9259696
Kimmel PL, Phillips TM, Simmens SJ, Peterson RA, Weihs KL, Alleyne S, Cruz I, Yanovski JA, Veis JH. Immunologic function and survival in hemodialysis patients. Kidney Int. 1998 Jul;54(1):236-44. doi: 10.1046/j.1523-1755.1998.00981.x.
PubMed 9648084
Yeun JY, Levine RA, Mantadilok V, Kaysen GA. C-Reactive protein predicts all-cause and cardiovascular mortality in hemodialysis patients. Am J Kidney Dis. 2000 Mar;35(3):469-76. doi: 10.1016/s0272-6386(00)70200-9.
PubMed 10692273
Kaysen GA. Biological basis of hypoalbuminemia in ESRD. J Am Soc Nephrol. 1998 Dec;9(12):2368-76. doi: 10.1681/ASN.V9122368.
PubMed 9848794
Patient mortality and survival. USRDS. United State Renal Data System. Am J Kidney Dis. 1997 Aug;30(2 Suppl 1):S86-106. No abstract available.
PubMed 9259695
Kaysen GA. Role of inflammation and its treatment in ESRD patients. Blood Purif. 2002;20(1):70-80. doi: 10.1159/000046988.
PubMed 11803162
Bologa RM, Levine DM, Parker TS, Cheigh JS, Serur D, Stenzel KH, Rubin AL. Interleukin-6 predicts hypoalbuminemia, hypocholesterolemia, and mortality in hemodialysis patients. Am J Kidney Dis. 1998 Jul;32(1):107-14. doi: 10.1053/ajkd.1998.v32.pm9669431.
PubMed 9669431

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 End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Dose Finding Study of Xigris (Drotrecogin Alfa Activated) as an Anti-coagulant in End Stage Renal Disease (ESRD) Patients Treated With Hemodialysis (HD)
ClinicalTrials.gov ID: NCT01227187
Acronym / sponsor ID: Xigris1003 / F1K-MC-1003
Conditions: End Stage Renal Disease
Keywords: Hemodialysis, Anticoagulation, Xigris, PTT
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: George Washington UniversityUniversity, hospital or other
Collaborators: Eli Lilly and Company
Study start: Oct 2008
Primary completion: Nov 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 25 Oct 2010 (estimated)
Results: Posted 3 Feb 2022

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 the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Xigris	Experimental	Drug: Drotrecogin alfa activated (Xigris)Drotrecogin alfa activated (Xigris) used as anticoagulant in patients treated with hemodialysis.

Who may qualify

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

Key inclusion criteria (2 listed)

>18
Usually used heparin with HD

Key exclusion criteria (8 listed)

Plt <100
Pregnancy
H/o bleeding diathesis
H/o CVA
Pt on Ticlid/plavix/warfarin

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
Drotrecogin alfa activated (Xigris)Also: Drotrecogin alfa (activated)We will test different dose regimens of Drotrecogin alfa activated (Xigris) to determine the optimal dose to achieve PTT between 65 and 100 secs. The initial patients will receive Xigris dosed at an infusion rate of 12 mcg/kg/h via pre-filter arterial drip chamber via a standard IV pump. The PTT will be assessed at baseline,15,30,60,120 and 180 mins. Xigris dose will be adjusted in the following patients if the afferent PTT rises above 100 secs (normal range 25-40 secs) or if PTT remains <65 secs. If PTT remains less than 65 secs, the dose will be increased to the second dose regiment of 18 mcg/kg/hr. The dose escalation will continue in increments of 6 mcg/kg/h to a maximum dose of 36 mcg/kg/h. Each patient will receive Xigris only once.	Drug	Xigris

Primary outcome

Mean Partial Thromboplastin Time (PTT) at 15 Minutes
Time frame: PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 30 Minutes
Time frame: PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 60 Minutes
Time frame: PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 120 Minutes
Time frame: PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 180 Minutes
Time frame: PTT level at 180 minutes after start up of Xigris during the hemodialysis treatment.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.

Results and safety

Results posted to the registry on 3 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
APC Initiation Dose of 12 μg/kg/h	1	1
APC Initiation Dose of 18 μg/kg/h	3	3
APC Initiation Dose of 24 μg/kg/h	3	3
APC Initiation Dose of 30 μg/kg/h	5	4

Primary outcome: Mean Partial Thromboplastin Time (PTT) at 15 Minutes

Time frame: PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.. Mean (Standard Deviation). Unit: Seconds

Measure	APC Initiation Dose 12 μg/kg/h n = 1	APC Initiation Dose 18 μg/kg/h n = 3	APC Initiation Dose 24 μg/kg/h n = 3	APC Initiation Dose 30 μg/kg/h n = 5
Value	38.4 (NA)	38.4 (4.6)	45.4 (5.1)	49.7 (12.0)

Primary outcome: Mean Partial Thromboplastin Time (PTT) at 30 Minutes

Time frame: PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment.. Mean (Standard Deviation). Unit: Seconds

Measure	APC Initiation Dose 12 μg/kg/h n = 1	APC Initiation Dose 18 μg/kg/h n = 3	APC Initiation Dose 24 μg/kg/h n = 3	APC Initiation Dose 30 μg/kg/h n = 5
Value	36.2 (NA)	35.7 (3.4)	48.2 (8.8)	51.3 (12.0)

Primary outcome: Mean Partial Thromboplastin Time (PTT) at 60 Minutes

Time frame: PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment.. Mean (Standard Deviation). Unit: Seconds

Measure	APC Initiation Dose 12 μg/kg/h n = 1	APC Initiation Dose 18 μg/kg/h n = 3	APC Initiation Dose 24 μg/kg/h n = 3	APC Initiation Dose 30 μg/kg/h n = 5
Value	39.8 (NA)	36.4 (1.4)	39.2 (8.0)	52.6 (16.1)

Primary outcome: Mean Partial Thromboplastin Time (PTT) at 120 Minutes

Time frame: PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment.. Mean (Standard Deviation). Unit: Seconds

Measure	APC Initiation Dose 12 μg/kg/h n = 1	APC Initiation Dose 18 μg/kg/h n = 3	APC Initiation Dose 24 μg/kg/h n = 3	APC Initiation Dose 30 μg/kg/h n = 4
Value	39.4 (NA)	42.8 (4.6)	51.2 (7.8)	54.1 (14.2)

Adverse events

Time frame: Enrollment until post-treatment day 14. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
APC Initiation Dose 12 μg/kg/h	0 of 1 (0%)	0 of 1 (0%)	0 of 1
APC Initiation Dose 18 μg/kg/h	0 of 3 (0%)	0 of 3 (0%)	0 of 3
APC Initiation Dose 24 μg/kg/h	0 of 3 (0%)	0 of 3 (0%)	0 of 3
APC Initiation Dose 30 μg/kg/h	0 of 5 (0%)	1 of 5 (20%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8840287Hakim RM, Held PJ, Stannard DC, Wolfe RA, Port FK, Daugirdas JT, Agodoa L. Effect of the dialysis membrane on mortality of chronic hemodialysis patients. Kidney Int. 1996 Aug;50(2):566-70. doi: 10.1038/ki.1996.350.
Background: PubMed 8172208Hakim RM, Breyer J, Ismail N, Schulman G. Effects of dose of dialysis on morbidity and mortality. Am J Kidney Dis. 1994 May;23(5):661-9. doi: 10.1016/s0272-6386(12)70276-7.
Background: PubMed 7573030Held PJ, Port FK, Webb RL, Wolfe RA, Bloembergen WE, Turenne MN, Holzman E, Ojo AO, Young EW, Mauger EA, et al. Excerpts from United States Renal Data System 1995 Annual Data Report. Am J Kidney Dis. 1995 Oct;26(4 Suppl 2):S1-186. No abstract available.
Background: PubMed 8840285Held PJ, Port FK, Wolfe RA, Stannard DC, Carroll CE, Daugirdas JT, Bloembergen WE, Greer JW, Hakim RM. The dose of hemodialysis and patient mortality. Kidney Int. 1996 Aug;50(2):550-6. doi: 10.1038/ki.1996.348.
Background: PubMed 9648085Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Cruz I, Veis JH. Psychosocial factors, behavioral compliance and survival in urban hemodialysis patients. Kidney Int. 1998 Jul;54(1):245-54. doi: 10.1046/j.1523-1755.1998.00989.x.
Background: PubMed 7027040Lowrie EG, Laird NM, Parker TF, Sargent JA. Effect of the hemodialysis prescription on patient morbidity: report from the National Cooperative Dialysis Study. N Engl J Med. 1981 Nov 12;305(20):1176-81. doi: 10.1056/NEJM198111123052003.
Background: PubMed 2333868Lowrie EG, Lew NL. Death risk in hemodialysis patients: the predictive value of commonly measured variables and an evaluation of death rate differences between facilities. Am J Kidney Dis. 1990 May;15(5):458-82. doi: 10.1016/s0272-6386(12)70364-5.
Background: PubMed 8366899Owen WF Jr, Lew NL, Liu Y, Lowrie EG, Lazarus JM. The urea reduction ratio and serum albumin concentration as predictors of mortality in patients undergoing hemodialysis. N Engl J Med. 1993 Sep 30;329(14):1001-6. doi: 10.1056/NEJM199309303291404.
Background: PubMed 9259696Causes of death. USRDS. United States Renal Data System. Am J Kidney Dis. 1997 Aug;30(2 Suppl 1):S107-17. No abstract available.
Background: PubMed 9648084Kimmel PL, Phillips TM, Simmens SJ, Peterson RA, Weihs KL, Alleyne S, Cruz I, Yanovski JA, Veis JH. Immunologic function and survival in hemodialysis patients. Kidney Int. 1998 Jul;54(1):236-44. doi: 10.1046/j.1523-1755.1998.00981.x.
Background: PubMed 10692273Yeun JY, Levine RA, Mantadilok V, Kaysen GA. C-Reactive protein predicts all-cause and cardiovascular mortality in hemodialysis patients. Am J Kidney Dis. 2000 Mar;35(3):469-76. doi: 10.1016/s0272-6386(00)70200-9.
Background: PubMed 9848794Kaysen GA. Biological basis of hypoalbuminemia in ESRD. J Am Soc Nephrol. 1998 Dec;9(12):2368-76. doi: 10.1681/ASN.V9122368.

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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.

Lakhmir S Chawla, MD principal investigator

George Washington University

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Drotrecogin alfa activated (Xigris) in people with End Stage Renal Disease, run by George Washington University 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 2 inclusion and 8 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 3 Feb 2022. 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. 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?

Yes. Results are posted in the registry (first posted 3 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Partial Thromboplastin Time (PTT) at 15 Minutes (time frame: PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.). The study lists 5 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 NCT01227187, which also lists 21 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 3 Feb 2022.