Anaemia Associated With Chronic Kidney DiseasePhase 3NCT04155125
A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
A Phase 3 study testing efepoetin alfa and Mircera in people with Anaemia Associated With Chronic Kidney Disease, run by PT Kalbe Genexine Biologics at 55 sites in 7 countries.
Trial summary
This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaemia Associated With Chronic Kidney Disease
- What is being tested?
- efepoetin alfa and Mircera
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 391 participants
- Where
- 55 sitesin 7 countries
- Study dates
- 2 Jul 2020to 30 Jun 2023
- 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
- Age should be greater than or equal to the minimum age of consent in the applicable country
- Stage 3 or 4 CKD (eGFR ≥ 15 and < 60 mL/min/1.73 m2)
- ESA-naive (no prior ESA use) subjects whose Hb at baseline is ≥ 8 g/dL and < 10 g/dL, or ESA prior users whose Hb at baseline is ≥ 8 g/dL and < 10 g/dL and who have stopped using ESA at least 12 weeks till the screening
- Ferritin ≥ 100 ng/mL and transferrin saturation (TSAT) ≥ 20%
- Subject must be willing to complete all study-related activities and follow-up visits
- Evidence of a signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Who cannot join
- Need for dialysis therapy expected in the next 12 months or rapid progression of CKD (e.g., eGFR decrease of >20% within 12 weeks)
- Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to screening, or blood transfusion is anticipated during the study period
- Have a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥ 1 g/dL, within the last 8 weeks prior to screening
- Have an unstable Hb for any reason, in the investigator's opinion
- Have non-renal anaemia (any anaemia where the investigator considers the anaemia is predominantly due to a non-renal cause. Non-renal causes include, but are not limited to vitamin B12 or folic acid deficiency, homozygous sickle-cell disease, thalassemia of all types, other non-renal cause of anaemia such as myelodysplasia or haematological malignancies)
- Platelet count of ≤ 50 x109/L
Show all 27Show fewer
- Vitamin B12 deficiency defined as total serum levels of < 181 pmol/L (246 pg/ml) 10
- Folic acid deficiency defined as total serum levels < 7.63 nmol/L (3.37 ng/mL) 10
- Pure red cell aplasia, or a history of pure red cell aplasia
- Poorly controlled hypertension defined as a sitting SBP ≥170 mmHg and/or DBP ≥100 mm Hg
- Chronic congestive heart failure (New York Heart Association class IV) or are otherwise at high risk for early withdrawal or interruption of the study (due to myocardial infarction, severe or unstable coronary artery disease, stroke, or severe liver disease) within the 12 weeks before screening or during screening
- Active or not active malignancy (except non-melanoma skin cancer) within five years before screening
- Planned live kidney transplantation scheduled within 52 weeks after the screening visit
- Uncontrolled hyperparathyroidism, in the investigator's opinion
- Uncontrolled hypothyroidism determined by the investigator that they cannot participate in the study
- Active acute or chronic infection, or uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus), or a C-reactive protein level > 15 mg/L. (Routinely screening for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) infection is not required in this protocol. By history or current clinical evidence, patients with active acute HBV or HCV infection should be excluded. Chronic HBV/HCV infection with LFTs > 3 times of normal are excluded. Known HIV positive patients are excluded)
- Immunosuppressive therapy (other than corticosteroids for a chronic condition, or tacrolimus/cyclosporine) within 12 weeks prior to baseline
- Life expectancy of less than 52 weeks
- Planned surgery during the study period (excluding minor skin excisions)
- Have received investigational drug(s) other than those of this study within 4 weeks prior to screening, or will receive investigational drug(s) other than those of this study during the study period
- History or clinical evidence of cardiovascular, haematologic or hepatic (ALT, AST, bilirubin values above three times the upper limit of normal [ULN] at screening) or any physical conditions that, in the opinion of the investigator, would compromise participation in the study
- With a cognitive or psychiatric condition rendering the subject unable to be cooperative with and complete study requirements
- Hypersensitivity to any one of the investigational drugs
- Subjects are, in the judgement of the investigator, otherwise inappropriate for entry into the study
- Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are KGBio or CRO employees directly involved in the conduct of the trial
- Participation in other studies involving same investigational drug(s) (Phases 1-4) of this study within 12 weeks before screening
- Females of childbearing potential or males who are unable/unwilling to take adequate contraceptive precautions defined by the protocol for the duration of the study and for at least 28 days after last dose of investigational product. Females have a positive pregnancy test result within 24 hours prior to study entry, is otherwise known to be pregnant, plans to become pregnant in the next 12 months or is currently breastfeeding.
Trial locations and contacts
55 sites in 7 countries.
55 sites in 7 countries
Taiwan15 sites
Changhua Christian Hospital
Changhua, 100
Hualien Tzu Chi Hospital
Hualien City, 970
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
Kaohsiung Chang Gung Hospital
Kaohsiung City, 83301
Keelung Chang Gung Memorial Hospital
Keelung, 204
Taiching Veterans General Hospital
Taichung, 40705
Kuang Tien General Hospital
Taichung, 433
Chi Mei Medical Center
Tainan, 433
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Tri-Service General Hospital
Taipei, 114
Far Eastern Memorial Hospital
Taipei, 220
Taipei Medical University - Shuang Ho Hospital
Taipei, 235
Linkou Chang Gung Memorial Hospital
Taoyuan, 833
Malaysia9 sites
Hospital Raja Permaisuri Bainun
Ipoh, 30450
Hospital Kajang
Kajang, 43000
Hospital Raja Perempuan Zainab II
Kota Bharu, 15200
University of Malaya Medical Centre
Kuala Lumpur, Selangor, 59100
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Hospital Tengku Ampuan Afzan
Kuantan, 25100
Hospital Serdang
Serdang, 43000
Seri Manjung Hospital
Seri Manjung, Perak, 32040
Hospital Sibu
Sibu, 96000
South Korea9 sites
Chungnam National University Hospital
Daejeon
Korea University Ansan Hospital
Gyeonggi-do
Seoul National University Bundang Hospital
Gyeonggi-do
The Catholic University of Korea Incheon St. Mary'S Hospital
Incheon
Chungnam National University Sejong Hospital
Sejong
Kyung Hee University Hospital At Gangdong
Seoul
The Catholic University of Korea Eunpyeong St. Mary'S Hospital
Seoul
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul
The Catholic University of Korea, Yeouido St. Mary'S Hospital
Seoul
Philippines7 sites
M3 Dialysis Center
Bacolod City, 6100
Baguio General Hospital Medical Center
Baguio City, 2600
Norzel Medical and Diagnostic Clinic
Cebu City, 6000
De La Salle Medical and Health Sciences Institute
Dasmariñas, 4114
Davao Doctors Hospital
Davao City, 8000
West Visayas State University Hospital
Iloilo City, 5000
National Kidney and Transplant Institute
Quezon, 1101
Indonesia6 sites
Rspad Gatot Soebroto
Jakarta Pusat
Rumah Sakit Islam Jakarta Cempaka Putih
Jakarta Pusat
Rumah Sakit Islam Jakarta Pondok Kopi
Jakarta Pusat
Rumah Sakit Pgi Cikini
Jakarta Pusat
Rumah Sakit Umum Pusat Fatmawati
Jakarta Pusat
Rumah Sakit Umum Pusat Nasional Dr Cipto Mangunkusumo
Jakarta Pusat
Thailand6 sites
Vajira Hospital
Bangkok, 10330
Siriraj Hospital
Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Thammasat University Hospital
Pathum Thani, 12120
Songklanagarind Hospital
Songkhla, 90110
Sunpasitthiprasong Hospital
Ubon Ratchathani, 34000
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Renal Research Gosford
Gosford, New South Wales, 2250
Launceston General Hospital
Launceston, Tasmania, 7250
About this study
Official title: Open-Label Randomised Controlled Trial of Efepoetin Alfa for Treatment of Anaemia Associated With Chronic Kidney Disease Patients Not on Dialysis (ND-CKD). A Non- Inferiority Trial Compared to Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA)
This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects who have CKD and are not on dialysis. ESA prior users who have stopped using ESA at least 12 weeks till screening will also be eligible for this study provided they fulfil all the subject entry criteria.
Read the detailed description
The study will consist of a 20-week correction period for dosage titration and Hb correction, followed by an 8-week evaluation period for efficacy assessments of corrective treatment. Subjects who respond to efepoetin alfa (defined as an increase in Hb ≥1.0 g/dL versus baseline and Hb level within 10 - 12 g/dL range without blood transfusion during the 28 weeks after the first dose) will be eligible to continue treatment, and will be randomised to receive subcutaneous efepoetin alfa either once every 2W or every 4W for an additional 24-week extension period to assess long-term safety and maintenance effect. Mircera responders will also be allowed to continue the drug during the extension period, receiving it every 4 weeks using the dose equal to twice the previous once-every-two-week dose. The safety data collected will be part of an ongoing pooled analysis of safety data from the efepoetin alfa clinical development program.
- Being tested
- efepoetin alfa, Mircera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efepoetin alfaDrug
The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period.
MirceraDrug
The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL.
| Study group | Role | What they receive |
|---|---|---|
| efepoetin alfa | Experimental | Route of administration: Subcutaneous Injection.
The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period. Receives: Drug: efepoetin alfa |
| Mircera | Placebo comparator | Route of administration: Subcutaneous Injection.
The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL. Receives: Drug: Mircera |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period
Measurement is done by an increase in Hb more than or equal to 1 g/dL compared with baseline and a Hb concentration within range of 10 - 12 g/dL inclusive without transfusion during evaluation period
Measured: Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks.
Secondary outcomes (1)
Characterise safety and tolerability of subcutaneous efepoetin alfa is being measured by based on the frequency of adverse events and on the number of out of range laboratory values.
Safety endpoints parameters including Serious Adverse Events (SAE) specified below
- Composite outcome of cardiovascular death or a nonfatal myocardial infarction or stroke
- All-cause mortality
- Cardiovascular mortality
- Acute myocardial infarction
- Heart failure
- Acute kidney injury defined according to Acute Kidney Injury Network (AKIN) criteria
- Abnormal clinical laboratory tests (haematology, biochemistry including serum ferritin and TSAT)
- Anti-efepoetin alfa or anti-Mircera antibody titres
- Clinically meaningful abnormal findings of vital signs
- Development of clinically meaningful electrocardiogram abnormalities
- Hospitalisations (excluding those for logistic reasons)
It is a composite outcome. Any abnormal test findings during the study will be helpful in reviewing the outcome.
Measured: Measurement from the time the subject provides informed consent through and including 28 calendar days after the last study drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start2 Jul 2020
- Primary completion30 Mar 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaemia Associated With Chronic Kidney DiseaseStudies 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
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Kalbe Genexine Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155125
- Sponsor's protocol ID
- GXE4KGBio-001
- Status last verified
- Dec 2023
- First submitted
- 29 Oct 2019
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Randomised Controlled Trial of Efepoetin Alfa for Treatment of Anaemia Associated With Chronic Kidney Disease Patients Not on Dialysis (ND-CKD). A Non- Inferiority Trial Compared to Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA)
- ClinicalTrials.gov ID
- NCT04155125
- Acronym / sponsor ID
- GXE4KGBio-001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- PT Kalbe Genexine BiologicsIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 Nov 2019 (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.
This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects who have CKD and are not on dialysis. ESA prior users who have stopped using ESA at least 12 weeks till screening will also be eligible for this study provided they fulfil all the subject entry criteria.
Detailed description
The study will consist of a 20-week correction period for dosage titration and Hb correction, followed by an 8-week evaluation period for efficacy assessments of corrective treatment. Subjects who respond to efepoetin alfa (defined as an increase in Hb ≥1.0 g/dL versus baseline and Hb level within 10 - 12 g/dL range without blood transfusion during the 28 weeks after the first dose) will be eligible to continue treatment, and will be randomised to receive subcutaneous efepoetin alfa either once every 2W or every 4W for an additional 24-week extension period to assess long-term safety and maintenance effect. Mircera responders will also be allowed to continue the drug during the extension period, receiving it every 4 weeks using the dose equal to twice the previous once-every-two-week dose. The safety data collected will be part of an ongoing pooled analysis of safety data from the efepoetin alfa clinical development program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| efepoetin alfa | Experimental | Drug: efepoetin alfaRoute of administration: Subcutaneous Injection. The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period. |
| Mircera | Placebo comparator | Drug: MirceraRoute of administration: Subcutaneous Injection. The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age should be greater than or equal to the minimum age of consent in the applicable country
- Stage 3 or 4 CKD (eGFR ≥ 15 and < 60 mL/min/1.73 m2)
- ESA-naive (no prior ESA use) subjects whose Hb at baseline is ≥ 8 g/dL and < 10 g/dL, or ESA prior users whose Hb at baseline is ≥ 8 g/dL and < 10 g/dL and who have stopped using ESA at least 12 weeks till the screening
- Ferritin ≥ 100 ng/mL and transferrin saturation (TSAT) ≥ 20%
- Subject must be willing to complete all study-related activities and follow-up visits
Key exclusion criteria (27 listed)
- Need for dialysis therapy expected in the next 12 months or rapid progression of CKD (e.g., eGFR decrease of >20% within 12 weeks)
- Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to screening, or blood transfusion is anticipated during the study period
- Have a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥ 1 g/dL, within the last 8 weeks prior to screening
- Have an unstable Hb for any reason, in the investigator's opinion
- Have non-renal anaemia (any anaemia where the investigator considers the anaemia is predominantly due to a non-renal cause. Non-renal causes include, but are not limited to vitamin B12 or folic acid deficiency, homozygous sickle-cell disease, thalassemia of all types, other non-renal cause of anaemia such as myelodysplasia or haematological malignancies)
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 |
|---|---|---|
| efepoetin alfaThe administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period. | Drug | efepoetin alfa |
| MirceraThe starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL. | Drug | Mircera |
Primary outcome
To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period
Time frame: Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks.
Measurement is done by an increase in Hb more than or equal to 1 g/dL compared with baseline and a Hb concentration within range of 10 - 12 g/dL inclusive without transfusion during evaluation period
1 secondary outcome
Characterise safety and tolerability of subcutaneous efepoetin alfa is being measured by based on the frequency of adverse events and on the number of out of range laboratory values.
Time frame: Measurement from the time the subject provides informed consent through and including 28 calendar days after the last study drug administration.
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 22 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
55 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing efepoetin alfa and Mircera in people with Anaemia Associated With Chronic Kidney Disease, run by PT Kalbe Genexine Biologics at 55 sites in 7 countries.
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 6 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: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in Taiwan, Malaysia, South Korea, Philippines, Indonesia and 2 more countries. 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.
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?
To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period (time frame: Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks.). 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 22 Dec 2023.