Renal Transplant RejectionPhase 4NCT02866682
Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients
A Phase 4 study testing Prograf and Tacrolimus in people with Renal Transplant Rejection, run by University of California, Los Angeles at 1 site in United States.
Trial summary
As the patents for brand-name immunosuppressive medications expire, there is increasing interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies showing bioequivalence, questions remain regarding the clinical impact of use of generic immunosuppression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Rejection
- What is being tested?
- Prograf and Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 11 Jun 2021
- Phase
- Phase 4
- 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
- Signed informed consent and or/assent
- Between the ages of 18 and 70 years, inclusive
- Current or future kidney transplant recipients, no more than 14 days after transplant and prior to hospital discharge. Inclusion of future kidney transplant recipients cannot exceed 30-days pre-transplant.
- Able to swallow tablets and capsules at the time of randomization
- Subjects must be receiving a primary or secondary kidney allograft from a deceased donor or from a non- HLA identical living donor
- Negative cross match test, and compatible (A, B, AB or O) blood type
Show all 12Show fewer
- Subjects must have no known contraindications to tacrolimus
- Women of childbearing potential (WOCBP) must have a negative pregnancy test and be willing to use 2 methods of contraception during the study and for 6 weeks after stopping the study drug.
- WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/cc). Women who are using oral, implanted, or injectable contraceptive hormones (intrauterine device), mechanical products or barrier methods (diaphragm, condoms, spermicides), are practicing abstinence, or have a sterile partner (e.g., vasectomy), will be considered of child bearing potential.
- In addition, WOCBP who are taking MMF must use methods of birth control as stipulated in the package insert, namely:
- Either intrauterine device, or partner with vasectomy, or one hormone (oral contraceptive pill, transdermal patch, vaginal ring, or progesterone injection or implant) and one barrier method (diaphragm or cervical cap with spermicide, contraceptive sponge, or male or female condom), or two barrier methods as described above.
- WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at the time of transplant.
Who cannot join
- Those who receive simultaneous combined organ transplants
- Subjects with clinically significant active infections (for example, those requiring hospitalization, or as judged by the Investigator) or malignancies
- Recipients who are concurrently receiving belatacept or anticipate to receive belatacept as part of their immunosuppressive regimen
- Subjects currently enrolled in another investigational device or drug study
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for 6 weeks after stopping the study drug
- Women who are breast-feeding or pregnant with a positive pregnancy test on enrollment or prior to study drug administration
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
- Any psychiatric or medical condition that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Kidney Transplant Research
Los Angeles, California, 90024
About this study
Official title: Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response
As the patents for brand-name immunosuppressive medications expire, there is increasing interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies showing bioequivalence, questions remain regarding the clinical impact of use of generic immunosuppression.
The most important immunosuppressive agent in the modern transplant era is arguably tacrolimus, a calcineurin-inhibitor with a narrow therapeutic index. This study seeks to answer the question regarding the clinical impact of generic tacrolimus use as measured primarily by acute rejection, loss of graft function, and patient death through a randomized trial of 2 phases: Brand tacrolimus only, and Generic A tacrolimus only. Given that kidney transplantations are the most commonly performed transplants with well-defined measures of rejection and graft failure, this organs will be studied in a six-center study designed to accrue the target number of transplant recipients within the one-year study period.
The study has now been branched off into 2 phases. Phase 1: consists of randomization of patients onto brand and generic tacrolimus. This was completed once 40 brand patients were enrolled. Phase 2: consists of patients being enrolled only on generic tacrolimus (standard of care from subject's insurance). This will be completed once there is a total of 160 generic participants. 200 participants total in the study.
Read the detailed description
A prospective, randomized, open-label, multicenter, parallel, observational study to assess safety and efficacy of 200 kidney transplant recipients comparing brand tacrolimus to generic tacrolimus over a one year follow up period. All subjects will receive other immunosuppressive medications including induction therapy (thymoglobulin, basiliximab, or no induction) and maintenance including mycophenolate mofetil and corticosteroid therapy as directed by standard-of-care at each center. Their medication information will be recorded in their study files.
The study population includes recipients of kidney allografts in the first 14 days after transplantation.
The totals of 7 visits over 12 months period are planned as follows. The blood samples specified below are for the translational research study labs. Subjects will continue to receive routine labs as part of their standard of care from their treating physician. These safety labs are done as part of their stand of care from their treating physician.
If the subject needs more study drug medication before his or her next study visit the subject will come in to the clinic to get a new supply.
First (Baseline) Visit (up to 14 days after transplant but before you are discharged from the hospital):
- Review and sign this consent form
- Review of your medical history
- Review of your current medications
- Review of your physical exam including vital signs (blood pressure, temperature, pulse and respiration rate), height and weight
- Review of clinical labs
- You will receive your study drug if you are in Part 1 of the study.
If you are a woman of child bearing potential, a pregnancy test will be completed prior to the start of the study. If you are pregnant, you cannot participate in this research study. You also cannot participate in this study if you are currently breastfeeding. You must use a medically acceptable method of birth control during the 1-year study period and for 6 weeks after the last dose of study medication.
It is possible that after the study doctor reviews your medical history and test results, he or she may tell you that you do not qualify to be in the study. If you do not qualify for the study, the doctor will tell you the reason(s) why. If you cannot be in this research study, you will not lose any medical benefits, you can still participate in other studies, and you can still receive the standard treatment prescribed by your physician.
After the Baseline Visit, you will have 6 additional study visits. These will be scheduled for 1, 2, 3, 6, 9, and 12 months after your transplant surgery. The following will occur at each visit:
Month 1, 2, 3, 6, and 9 Visits:
- Review of your current medications
- Review of your physical exam including vital signs (blood pressure, temperature, pulse and respiration rate), height and weight
- Review of any changes in your health and any reactions to the study medication will be recorded
- Review of your routine standard of care lab results
- Return completed dosing diary and receive new dosing diary
- You will receive your study drug if you are in Part 1 of the study
Month 12 Visit (End of Study Visit):
- Review of your current medications
- Review of any changes in your health and any reactions to the study medication will be recorded
- Review of your routine standard of care lab result
- Return your final completed dosing diary
- Return any study drug remaining in your possession to the study team if you are in Part 1 of the study
If you are Part 1 and require more study medication before your next study visit, you will come in to the clinic to get a new supply. If you are participating in Part 2, you will obtain more study drug from your local pharmacy.
You will continue having your routine blood and urine collections to monitor your kidney function as part of your standard of care treatment at UCLA, UCSD, UCI, and UCD. The schedule for these routine blood and urine collections will depend on your condition and will be at your treating physician's discretion.
Adherence will be measured with daily medication diaries and with the coefficient of variation of tacrolimus in subjects' blood.
- Conditions
- Renal Transplant Rejection
- Being tested
- Prograf, Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrografDrug
Brand Drug for the duration of the study.
TacrolimusDrug
Generic
| Study group | Role | What they receive |
|---|---|---|
| Brand Tacrolimus Only : Prograf | Other | Arm 1 will receive brand tacrolimus for the entire study Receives: Drug: Prograf |
| Generic A Only | Other | Arm 2 will receive specific generic tacrolimus for the entire study Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Occurrence of Acute Rejection, Failure, Death
The definition of graft failure includes re-transplant and/or death and, in case of kidney transplant, also includes return to dialysis. Acute rejection was defined as biopsy-proven rejection according to Banff 2007 criteria. Please see the following article for details of the Banff '07 classification: https://www.sciencedirect.com/science/article/pii/S1600613522056428?via%3Dihub.
Measured: 1 year post-transplant
Secondary outcomes (9)
Number of Participants With Graft Rejection at 1 Year
Rejection was defined as biopsy-proven rejection according to Banff 2007 criteria. Please see the following article for details of the Banff '07 classification: https://www.sciencedirect.com/science/article/pii/S1600613522056428?via%3Dihub.
Measured: 1 year post-transplant
Number of Participants With Graft Failure at 1 Year
Graft failure as determined by return to dialysis, death, or re-transplant
Measured: 1 year post-transplant
Number of Participants With Infectious Episodes at 1 Year
Infectious episodes are defined as a positive test result for an infection.
Measured: 1 year post-transplant
Number of Participants With Malignancy at 1 Year
Malignancy is defined as physician reported malignancy according to review of participants' medical history.
Measured: 1 year post-transplant
Death or Loss-to-follow-up at 1 Year
Measured: 1 year post-transplant
Changes in Lymphocyte Subpopulations and Production of Donor Specific HLA Antibodies
Measured: post-transplant
Number of Participants Who Adhered to Medication Regimen
Patient adherence was assessed by their physician with participants marked as "adherent," "non-adherent," or "unknown."
Measured: post-transplant
Quality of Life With Medication Regimen
Measured: post-transplant
Satisfaction With Medication Regimen
Measured: post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start1 Mar 2018
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant RejectionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Suphamai Bunnapradist, University of California, Los Angeles
- Investigators
- Suphamai Bunnapradist, M.D.,M.S., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866682
- Sponsor's protocol ID
- 14-001423
- Status last verified
- Apr 2023
- First submitted
- 26 Jul 2016
- Last updated
- 28 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PubMed 36094829
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response
- ClinicalTrials.gov ID
- NCT02866682
- Acronym / sponsor ID
- 14-001423
- Conditions
- Renal Transplant Rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Posted 28 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As the patents for brand-name immunosuppressive medications expire, there is increasing interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies showing bioequivalence, questions remain regarding the clinical impact of use of generic immunosuppression.
The most important immunosuppressive agent in the modern transplant era is arguably tacrolimus, a calcineurin-inhibitor with a narrow therapeutic index. This study seeks to answer the question regarding the clinical impact of generic tacrolimus use as measured primarily by acute rejection, loss of graft function, and patient death through a randomized trial of 2 phases: Brand tacrolimus only, and Generic A tacrolimus only. Given that kidney transplantations are the most commonly performed transplants with well-defined measures of rejection and graft failure, this organs will be studied in a six-center study designed to accrue the target number of transplant recipients within the one-year study period.
The study has now been branched off into 2 phases. Phase 1: consists of randomization of patients onto brand and generic tacrolimus. This was completed once 40 brand patients were enrolled. Phase 2: consists of patients being enrolled only on generic tacrolimus (standard of care from subject's insurance). This will be completed once there is a total of 160 generic participants. 200 participants total in the study.
Detailed description
A prospective, randomized, open-label, multicenter, parallel, observational study to assess safety and efficacy of 200 kidney transplant recipients comparing brand tacrolimus to generic tacrolimus over a one year follow up period. All subjects will receive other immunosuppressive medications including induction therapy (thymoglobulin, basiliximab, or no induction) and maintenance including mycophenolate mofetil and corticosteroid therapy as directed by standard-of-care at each center. Their medication information will be recorded in their study files.
The study population includes recipients of kidney allografts in the first 14 days after transplantation.
The totals of 7 visits over 12 months period are planned as follows. The blood samples specified below are for the translational research study labs. Subjects will continue to receive routine labs as part of their standard of care from their treating physician. These safety labs are done as part of their stand of care from their treating physician.
If the subject needs more study drug medication before his or her next study visit the subject will come in to the clinic to get a new supply.
First (Baseline) Visit (up to 14 days after transplant but before you are discharged from the hospital):
- Review and sign this consent form
- Review of your medical history
- Review of your current medications
- Review of your physical exam including vital signs (blood pressure, temperature, pulse and respiration rate), height and weight
- Review of clinical labs
- You will receive your study drug if you are in Part 1 of the study.
If you are a woman of child bearing potential, a pregnancy test will be completed prior to the start of the study. If you are pregnant, you cannot participate in this research study. You also cannot participate in this study if you are currently breastfeeding. You must use a medically acceptable method of birth control during the 1-year study period and for 6 weeks after the last dose of study medication.
It is possible that after the study doctor reviews your medical history and test results, he or she may tell you that you do not qualify to be in the study. If you do not qualify for the study, the doctor will tell you the reason(s) why. If you cannot be in this research study, you will not lose any medical benefits, you can still participate in other studies, and you can still receive the standard treatment prescribed by your physician.
After the Baseline Visit, you will have 6 additional study visits. These will be scheduled for 1, 2, 3, 6, 9, and 12 months after your transplant surgery. The following will occur at each visit:
Month 1, 2, 3, 6, and 9 Visits:
- Review of your current medications
- Review of your physical exam including vital signs (blood pressure, temperature, pulse and respiration rate), height and weight
- Review of any changes in your health and any reactions to the study medication will be recorded
- Review of your routine standard of care lab results
- Return completed dosing diary and receive new dosing diary
- You will receive your study drug if you are in Part 1 of the study
Month 12 Visit (End of Study Visit):
- Review of your current medications
- Review of any changes in your health and any reactions to the study medication will be recorded
- Review of your routine standard of care lab result
- Return your final completed dosing diary
- Return any study drug remaining in your possession to the study team if you are in Part 1 of the study
If you are Part 1 and require more study medication before your next study visit, you will come in to the clinic to get a new supply. If you are participating in Part 2, you will obtain more study drug from your local pharmacy.
You will continue having your routine blood and urine collections to monitor your kidney function as part of your standard of care treatment at UCLA, UCSD, UCI, and UCD. The schedule for these routine blood and urine collections will depend on your condition and will be at your treating physician's discretion.
Adherence will be measured with daily medication diaries and with the coefficient of variation of tacrolimus in subjects' blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brand Tacrolimus Only : Prograf | Other | Drug: PrografArm 1 will receive brand tacrolimus for the entire study |
| Generic A Only | Other | Drug: TacrolimusArm 2 will receive specific generic tacrolimus for the entire study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent and or/assent
- Between the ages of 18 and 70 years, inclusive
- Current or future kidney transplant recipients, no more than 14 days after transplant and prior to hospital discharge. Inclusion of future kidney transplant recipients cannot exceed 30-days pre-transplant.
- Able to swallow tablets and capsules at the time of randomization
- Subjects must be receiving a primary or secondary kidney allograft from a deceased donor or from a non- HLA identical living donor
Key exclusion criteria (8 listed)
- Those who receive simultaneous combined organ transplants
- Subjects with clinically significant active infections (for example, those requiring hospitalization, or as judged by the Investigator) or malignancies
- Recipients who are concurrently receiving belatacept or anticipate to receive belatacept as part of their immunosuppressive regimen
- Subjects currently enrolled in another investigational device or drug study
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for 6 weeks after stopping the study drug
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 |
|---|---|---|
| PrografBrand Drug for the duration of the study. | Drug | Brand Tacrolimus Only : Prograf |
| TacrolimusGeneric | Drug | Generic A Only |
Primary outcome
Time to First Occurrence of Acute Rejection, Failure, Death
Time frame: 1 year post-transplant
The definition of graft failure includes re-transplant and/or death and, in case of kidney transplant, also includes return to dialysis. Acute rejection was defined as biopsy-proven rejection according to Banff 2007 criteria. Please see the following article for details of the Banff '07 classification: https://www.sciencedirect.com/science/article/pii/S1600613522056428?via%3Dihub.
9 secondary outcomes
Number of Participants With Graft Rejection at 1 Year
Time frame: 1 year post-transplant
Number of Participants With Graft Failure at 1 Year
Time frame: 1 year post-transplant
Number of Participants With Infectious Episodes at 1 Year
Time frame: 1 year post-transplant
Number of Participants With Malignancy at 1 Year
Time frame: 1 year post-transplant
Death or Loss-to-follow-up at 1 Year
Time frame: 1 year post-transplant
Changes in Lymphocyte Subpopulations and Production of Donor Specific HLA Antibodies
Time frame: post-transplant
Number of Participants Who Adhered to Medication Regimen
Time frame: post-transplant
Quality of Life With Medication Regimen
Time frame: post-transplant
Satisfaction With Medication Regimen
Time frame: post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36094829Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
- Individual participant dataSharing planned: Yes
Related trials for Renal Transplant Rejection
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
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.
Suphamai Bunnapradist, M.D.,M.S. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prograf and Tacrolimus in people with Renal Transplant Rejection, run by University of California, Los Angeles 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 12 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 28 Apr 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 28 Apr 2023). 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?
Time to First Occurrence of Acute Rejection, Failure, Death (time frame: 1 year post-transplant). 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 NCT02866682, 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 28 Apr 2023.