End Stage Renal Disease (ESRD)Phase 4NCT06597201
Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
A Phase 4 study testing amino acid (15) peritoneal dialysis solution and glucose peritoneal dialysis solution in people with End Stage Renal Disease (ESRD), run by Chengdu Qingshan Likang Pharmaceutical Co., Ltd at 21 sites in China.
Trial summary
This is a multicenter, randomized, parallel controlled Phase IV clinical study to evaluate the safety and efficacy of amino acid (15) peritoneal dialysis solution in patients undergoing peritoneal dialysis with malnutrition in CAPD patients undergoing peritoneal dialysis maintenance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- amino acid (15) peritoneal dialysis solution and glucose peritoneal dialysis solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 21 sitesChina
- Study dates
- 9 Aug 2024to 29 Jun 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age (including 18 and 75 years of age), regardless of sex;
- Stable CAPD patients treated with peritoneal dialysis for greater than or equal to 3 months;
- 25 ≤ serum ALB ≤ 40 g/L on two consecutive occasions prior to enrollment (two occasions one week apart);
- Blood potassium ≥ 3.5 mmol/L
- C-reactive protein (CRP) ≤ 2 x upper limit of normal (ULN);
- Carbon dioxide binding capacity >18 mmol/L;
- Subjects voluntarily sign an informed consent form in writing prior to the commencement of any procedures related to the study, fully understand the purpose and significance of the trial, and are willing to comply with the trial protocol.
Who cannot join
- Within the past 3 months prior to the screening period, there has been a history of peritonitis, other infections, or inflammatory diseases, with hospitalization records;
- The possibility of receiving a kidney transplant during the study period;
- Patients with inadequate dialysis and screening period kt/v<1.4;
- Patients with hemoglobin less than 80g/L during the screening period;
- Patients who have used amino acid (15) peritoneal dialysate within 6 months prior to the screening period.
- Patients with bleeding events (active gastrointestinal hemorrhage, cerebral hemorrhage), cardiovascular and cerebrovascular events (cerebral infarction, myocardial infarction, etc., and NYHA grade ≥3 of cardiac function) within 30 days before screening period.
Show all 13Show fewer
- In patients with active diarrhea during the screening period, as assessed by investigators, affecting nutrient absorption(Except for patients with chronic diarrhea, stool frequency < 3 times/day);
- patients with contraindications to amino acid (15) peritoneal dialysis solutions: 1) hypersensitivity to any of the components of the product; 2) Serum urea level >38 mmol/l; 3) Presence of uremic symptoms such as marked loss of appetite, nausea and vomiting at the time of screening; 4) Various inborn abnormalities of amino acid metabolism; 5) hepatic insufficiency (active hepatitis); active hepatitis B or C, cirrhosis, active liver disease or positive seropositivity for human immunodeficiency virus (HIV) within 6 months prior to screening; 6) Uncorrectable mechanical defects that the investigator assesses as affecting efficacy or increasing the risk of infection; 7) History of loss of peritoneal function or impairment of peritoneal function due to extensive adhesions;
- Suffers from a malignant tumor or has a life expectancy of \<6 months;
- Routine daily use of 4.25% glucose dialysis solution during the screening period;
- Diabetic subjects with poor prior glycemic control, e.g., HbAlc > 8%;
- Women during pregnancy or breastfeeding;
- Other circumstances that, in the opinion of the investigator, may make participation in this study inappropriate.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
China21 sites, 21 recruiting
- Recruiting
Peking University People&'s Hospital
Beijing, Beijing Municipality, 100044
Li Zuo, 86 13910028495, zuolimd@yeah.net
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Hao Zhang, 86 13975806919, zhanghaoliaoqing@163.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
Ping Fu, 86 028-85422335, fupinghx@163.com
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Xiaohui Liao, 86 13594350439, 1263201771@qq.com
- Recruiting
Ganzhou People&#39;s Hospital
Ganzhou
Dehui Liu, 86 19979819277, liudehui2008@126.com
- Recruiting
Affiliated Hospital of Guangdong Medical University
Guangdong
Cuiwei Yao, 86 13671458718, yaocuiwei826@163.com
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
Wei Chen, 86 13924150966, vvchen99@126.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Yonggui Wu, 86 13955178900, wuyongguixialiang@163.com
- Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou
Santao Ou, 86 13679676835, 422216756@qq.com
- Recruiting
Meishan Hospital, West China Hospital, Sichuan University (Meishan People's Hospital)
Meishan
Zaizhi Zhu, 86 15282333398, zhuzaizhi36@sina.cn
- Recruiting
Jiangsu Province Hosipital
Nanjing
Huijuan Mao, 86 13851746819, huijuanmao@126.com
- Recruiting
The Affiliated Hospital of Nanjing university Medical School
Nanjing
Chunming Jiang, 86 13815884488, guloujiang@sina.com
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning
Zhenhua Yang, 86 13978806396, 593456108@qq.com
- Recruiting
Shanghai Sixth People&amp;#39;s Hospital Affiliated to Shanghai JiaoTong University
Shanghai
Niansong Wang, 86 18930177399, wangniansong2012@163.com
- Recruiting
General Hospital of Northern Theater Command
Shenyang
Yanning Zhang, 86 18604105316, fupinghx@163.com
- Recruiting
Wuhan NO.1 Hospital
Wuhan, Hubei
Fei Xiong, 86 13986234626, xiongf23@sina.com
- Recruiting
The Central Hospital of Wuhan
Wuhan
Wenli Chen, 86 13307127509, whwenli@163.com
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen
Hancheng Guo, 86 13606913285, 1104996835@qq.com
- Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang
Xiangdong Liu, 86 18568266234, azmlxd@163.com
- Recruiting
The Second People's Hospital of Yibin City
Yibin
Lei Zhu, 86 13547701638, 85989885@qq.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Zhanzheng Zhao, 86 13938525666, zhanzhengzhao@zzu.edu.cn
About this study
Official title: Multicenter, Prospective, Open-label, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
This is a multicenter, randomized, parallel controlled Phase IV clinical study to evaluate the safety and efficacy of amino acid (15) peritoneal dialysis solution in patients undergoing peritoneal dialysis with malnutrition in CAPD patients undergoing peritoneal dialysis maintenance.
Read the detailed description
After the subjects signed the informed consent, they entered the screening period (D-28 to D-1) for corresponding examination. Participants who were successfully screened were examined at baseline (D-3 to D-1) to re-verify the inclusion criteria. After re-verification of successful screening subjects, they were enrolled in 1:1 parallel groups according to the research center: experimental group treated with amino acid (15) peritoneal dialysate; Control group - glucose peritoneal dialysate treatment. Subjects were randomly enrolled and given the experimental drug from the next morning according to the randomized results. Subjects in the experimental group were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once a day in the morning, and were subsequently treated with conventional glucose peritoneal dialysate (lactate). Control subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysis solution (lactate) (2L) once. The number of peritoneal dialysate exchange, the amount of fluid exchange and the duration of abdominal retention were adjusted by the researchers according to the specific conditions of the patients. Efficacy and safety were observed during the treatment period (D1-D90). Blood routine and blood biochemistry were monitored for 30 days, 60 days and 90 days of treatment. nPNA, AMC, MAMC, SGA, BMI, Kt/V, etc. are monitored only at 90 days. The total daily ultrafiltration volume of the patients (the experimental group also recorded the ultrafiltration volume of amino acid peritoneal fluid), and all adverse events (aes) and serious adverse events (SAEs) were recorded in detail.
- Conditions
- End Stage Renal Disease (ESRD)
- Being tested
- amino acid (15) peritoneal dialysis solution, glucose peritoneal dialysis solution
- Keywords
- End stage renal disease, peritoneal dialysis solution, malnutrition
- Medical subject headings
- Kidney Failure, Chronic, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amino acid (15) peritoneal dialysis solutionDrug
Subjects were treated with 1 bag of amino acid (15) peritoneal dialysis solution (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate).
glucose peritoneal dialysis solutionDrug
Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Subjects were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate). Receives: Drug: amino acid (15) peritoneal dialysis solution |
| control group | Active comparator | Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once. Receives: Drug: glucose peritoneal dialysis solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALB
To compare the difference in change from baseline in serum albumin (ALB) after 90 days of treatment of CAPD patients with amino acid (15) peritoneal dialysis solution versus conventional glucose peritoneal dialysis solution (lactate).
Measured: After 90 days of treatment
Secondary outcomes (8)
serum transferrin
To compare the changes of serum transferrin in CAPD patients treated with amino acid (15) peritoneal dialysate and conventional glucose peritoneal dialysate (lactate) at 30 days, 60 days and 90 days compared with baseline.
Measured: After 30, 60, and 90 days of treatment
arm muscle circumference (AMC)
omparison of standardized upper arm muscle circumference (AMC) changes from baseline after fasting peritoneal dialysis fluid emptying between amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) in CAPD patients treated for 90 days.
Measured: After 90 days of treatment
standardized protein nitrogen occurrence rate (nPNA)
To compare the change of standardized protein nitrogen occurrence rate (nPNA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
Measured: After 90 days of treatment
subjective comprehensive nutritional assessment (SGA)
To compare the change of subjective comprehensive nutritional assessment (SGA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
Measured: After 90 days of treatment
middle arm muscle circumference (MAMC)
To compare the change of middle arm muscle circumference (MAMC) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
Measured: After 90 days of treatment
serum prealbumin
To compare the changes of serum prealbumin in CAPD patients treated with amino acid (15) peritoneal dialysate and conventional glucose peritoneal dialysate (lactate) at 30 days, 60 days and 90 days compared with baseline.
Measured: After 30, 60, and 90 days of treatment
serum albumin
To compare the changes of serum albumin in CAPD patients treated with amino acid (15) peritoneal dialysate and conventional glucose peritoneal dialysate (lactate) at 30 days, 60 days and 90 days compared with baseline.
Measured: After 30, 60, and 90 days of treatment
body mass index (BMI)
To compare the change of standardized protein nitrogen occurrence rate (nPNA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
Measured: After 90 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Aug 2024
- Primary completion29 Jun 2025 (estimated)
- Study completion29 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease (ESRD)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Qingshan Likang Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597201
- Sponsor's protocol ID
- AAD-QSLK-401
- Status last verified
- Dec 2024
- First submitted
- 9 Sep 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
My Thuc LT, Dung NQ, Ha VN, Tam ND, Hang Nga NT. Actual diet and nutritional deficiencies status in children on peritoneal dialysis at the Vietnam National Hospital of Pediatrics. Saudi J Kidney Dis Transpl. 2019 Jul-Aug;30(4):924-931. doi: 10.4103/1319-2442.265470.
PubMed 31464251Kopple JD, Bernard D, Messana J, Swartz R, Bergstrom J, Lindholm B, Lim V, Brunori G, Leiserowitz M, Bier DM, et al. Treatment of malnourished CAPD patients with an amino acid based dialysate. Kidney Int. 1995 Apr;47(4):1148-57. doi: 10.1038/ki.1995.164.
PubMed 7783413Tjiong HL, Swart R, van den Berg JW, Fieren MW. Amino Acid-based peritoneal dialysis solutions for malnutrition: new perspectives. Perit Dial Int. 2009 Jul-Aug;29(4):384-93.
PubMed 19602603
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Open-label, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
- ClinicalTrials.gov ID
- NCT06597201
- Acronym / sponsor ID
- AAD-QSLK-401
- Conditions
- End Stage Renal Disease (ESRD)
- Keywords
- End stage renal disease, peritoneal dialysis solution, malnutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chengdu Qingshan Likang Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 29 Jun 2025 (estimated)
- Study completion
- 29 Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, parallel controlled Phase IV clinical study to evaluate the safety and efficacy of amino acid (15) peritoneal dialysis solution in patients undergoing peritoneal dialysis with malnutrition in CAPD patients undergoing peritoneal dialysis maintenance.
Detailed description
After the subjects signed the informed consent, they entered the screening period (D-28 to D-1) for corresponding examination. Participants who were successfully screened were examined at baseline (D-3 to D-1) to re-verify the inclusion criteria. After re-verification of successful screening subjects, they were enrolled in 1:1 parallel groups according to the research center: experimental group treated with amino acid (15) peritoneal dialysate; Control group - glucose peritoneal dialysate treatment. Subjects were randomly enrolled and given the experimental drug from the next morning according to the randomized results. Subjects in the experimental group were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once a day in the morning, and were subsequently treated with conventional glucose peritoneal dialysate (lactate). Control subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysis solution (lactate) (2L) once. The number of peritoneal dialysate exchange, the amount of fluid exchange and the duration of abdominal retention were adjusted by the researchers according to the specific conditions of the patients. Efficacy and safety were observed during the treatment period (D1-D90). Blood routine and blood biochemistry were monitored for 30 days, 60 days and 90 days of treatment. nPNA, AMC, MAMC, SGA, BMI, Kt/V, etc. are monitored only at 90 days. The total daily ultrafiltration volume of the patients (the experimental group also recorded the ultrafiltration volume of amino acid peritoneal fluid), and all adverse events (aes) and serious adverse events (SAEs) were recorded in detail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: amino acid (15) peritoneal dialysis solutionSubjects were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate). |
| control group | Active comparator | Drug: glucose peritoneal dialysis solutionSubjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 75 years of age (including 18 and 75 years of age), regardless of sex;
- Stable CAPD patients treated with peritoneal dialysis for greater than or equal to 3 months;
- 25 ≤ serum ALB ≤ 40 g/L on two consecutive occasions prior to enrollment (two occasions one week apart);
- Blood potassium ≥ 3.5 mmol/L
- C-reactive protein (CRP) ≤ 2 x upper limit of normal (ULN);
Key exclusion criteria (13 listed)
- Within the past 3 months prior to the screening period, there has been a history of peritonitis, other infections, or inflammatory diseases, with hospitalization records;
- The possibility of receiving a kidney transplant during the study period;
- Patients with inadequate dialysis and screening period kt/v<1.4;
- Patients with hemoglobin less than 80g/L during the screening period;
- Patients who have used amino acid (15) peritoneal dialysate within 6 months prior to the screening period.
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 |
|---|---|---|
| amino acid (15) peritoneal dialysis solutionSubjects were treated with 1 bag of amino acid (15) peritoneal dialysis solution (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate). | Drug | experimental group |
| glucose peritoneal dialysis solutionSubjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once. | Drug | control group |
Primary outcome
ALB
Time frame: After 90 days of treatment
To compare the difference in change from baseline in serum albumin (ALB) after 90 days of treatment of CAPD patients with amino acid (15) peritoneal dialysis solution versus conventional glucose peritoneal dialysis solution (lactate).
8 secondary outcomes
serum transferrin
Time frame: After 30, 60, and 90 days of treatment
arm muscle circumference (AMC)
Time frame: After 90 days of treatment
standardized protein nitrogen occurrence rate (nPNA)
Time frame: After 90 days of treatment
subjective comprehensive nutritional assessment (SGA)
Time frame: After 90 days of treatment
middle arm muscle circumference (MAMC)
Time frame: After 90 days of treatment
serum prealbumin
Time frame: After 30, 60, and 90 days of treatment
serum albumin
Time frame: After 30, 60, and 90 days of treatment
body mass index (BMI)
Time frame: After 90 days of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Background: PubMed 31464251My Thuc LT, Dung NQ, Ha VN, Tam ND, Hang Nga NT. Actual diet and nutritional deficiencies status in children on peritoneal dialysis at the Vietnam National Hospital of Pediatrics. Saudi J Kidney Dis Transpl. 2019 Jul-Aug;30(4):924-931. doi: 10.4103/1319-2442.265470.
- Background: PubMed 7783413Kopple JD, Bernard D, Messana J, Swartz R, Bergstrom J, Lindholm B, Lim V, Brunori G, Leiserowitz M, Bier DM, et al. Treatment of malnourished CAPD patients with an amino acid based dialysate. Kidney Int. 1995 Apr;47(4):1148-57. doi: 10.1038/ki.1995.164.
- Background: PubMed 19602603Tjiong HL, Swart R, van den Berg JW, Fieren MW. Amino Acid-based peritoneal dialysis solutions for malnutrition: new perspectives. Perit Dial Int. 2009 Jul-Aug;29(4):384-93.
- Individual participant dataSharing planned: No
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amino acid (15) peritoneal dialysis solution and glucose peritoneal dialysis solution in people with End Stage Renal Disease (ESRD), run by Chengdu Qingshan Likang Pharmaceutical Co., Ltd at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Deng (86 136 9940 1416, dq0416@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALB (time frame: After 90 days of treatment). 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 NCT06597201, which also lists 3 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 30 Dec 2024.