Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis SolutionPhase 4NCT06358820
Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution
A Phase 4 study testing Amino acid peritoneal dialysis solution in people with Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution, run by The People's Hospital of Gaozhou at 1 site in China.
Trial summary
This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution
- What is being tested?
- Amino acid peritoneal dialysis solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2023to 7 Jan 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For uremic patients with malnutrition during the screening period, maintenance peritoneal dialysis should be performed for at least 3 months. The standard for malnutrition should meet at least two of the following items: (1) serum albumin level<3.5g/dL (35g/L), (2) prealbumin<300mg/L, (3) modifiedSubjective Global Assessment (SGA) with a score of>7;
- Blood urea nitrogen ≤ 38mmol/L;
- The patient's age is between 18 and 75 years old;
- The patient signs an informed consent form.
Who cannot join
- Individuals who are allergic to any amino acids or excipients in this product
- More than one occurrence of peritonitis in the past three months; Peritonitis or hospitalization within the past month;
- Patients with hyperthyroidism, systemic infection, fever, and other high catabolic metabolic diseases, as well as those who are taking drugs that affect tissue metabolism, such as corticosteroids;
- Congenital amino acid metabolism deficiency disease, acute severe pancreatitis, severe hyperbilirubinemia 5. Patients with malignant tumor metastasis or spread, residual cancer after treatment, coagulation dysfunction, aplastic anemia, heart, brain, lung and other serious system diseases;
- 6. Possible kidney transplantation during the trial period; 7. Active phase of hepatitis B or C, liver cirrhosis, active liver disease, liver dysfunction, or positive serum reaction of human immunodeficiency virus (HIV); 8. Those who have participated in clinical trials of other drugs within the three months prior to enrollment; 9. Pregnant and lactating women; 10. Those who are mentally unable to cooperate; 11. Failure to sign a written informed consent form; 12. Unable or unwilling to comply with the experimental protocol approved by the researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status in Maintenance Peritoneal Dialysis Patients: a Multicenter, Open, Prospective, Self Controlled Clinical Study
This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded.
- Being tested
- Amino acid peritoneal dialysis solution
- Keywords
- amino acid peritoneal dialysis solution；peritoneal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid peritoneal dialysis solutionDrug
Each subject received treatment with 1 bag of amino acid peritoneal dialysis daily and 2-4 bags of glucose peritoneal dialysis solution daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Self Control | Other | Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment. Receives: Drug: Amino acid peritoneal dialysis solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Albumin
Changes in blood albumin levels
Measured: 6 months
Prealbumin
Changes in blood prealbumin levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start3 Dec 2023
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
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 Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis SolutionStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- The People's Hospital of Gaozhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, deng shanshan, The People's Hospital of Gaozhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358820
- Sponsor's protocol ID
- PHGaozhou
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2024
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng S, Xuan H, Chen L, Su X, Su Y, Lu Y, Zhu M, Yang X, Luo C, Shi W. Overnight-dwelled amino acid-based peritoneal dialysis solutions for malnutrition in CAPD: a prospective real-world study. Int Urol Nephrol. 2026 Feb;58(2):661-671. doi: 10.1007/s11255-025-04749-y. Epub 2025 Aug 27.
PubMed 40864356
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status in Maintenance Peritoneal Dialysis Patients: a Multicenter, Open, Prospective, Self Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06358820
- Acronym / sponsor ID
- PHGaozhou
- Keywords
- amino acid peritoneal dialysis solution；peritoneal dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- The People's Hospital of GaozhouUniversity, hospital or other
- Study start
- 3 Dec 2023 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self Control | Other | Drug: Amino acid peritoneal dialysis solutionCompare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For uremic patients with malnutrition during the screening period, maintenance peritoneal dialysis should be performed for at least 3 months. The standard for malnutrition should meet at least two of the following items: (1) serum albumin level<3.5g/dL (35g/L), (2) prealbumin<300mg/L, (3) modifiedSubjective Global Assessment (SGA) with a score of>7;
- Blood urea nitrogen ≤ 38mmol/L;
- The patient's age is between 18 and 75 years old;
- The patient signs an informed consent form.
Key exclusion criteria (5 listed)
- Individuals who are allergic to any amino acids or excipients in this product
- More than one occurrence of peritonitis in the past three months; Peritonitis or hospitalization within the past month;
- Patients with hyperthyroidism, systemic infection, fever, and other high catabolic metabolic diseases, as well as those who are taking drugs that affect tissue metabolism, such as corticosteroids;
- Congenital amino acid metabolism deficiency disease, acute severe pancreatitis, severe hyperbilirubinemia 5. Patients with malignant tumor metastasis or spread, residual cancer after treatment, coagulation dysfunction, aplastic anemia, heart, brain, lung and other serious system diseases;
- 6. Possible kidney transplantation during the trial period; 7. Active phase of hepatitis B or C, liver cirrhosis, active liver disease, liver dysfunction, or positive serum reaction of human immunodeficiency virus (HIV); 8. Those who have participated in clinical trials of other drugs within the three months prior to enrollment; 9. Pregnant and lactating women; 10. Those who are mentally unable to cooperate; 11. Failure to sign a written informed consent form; 12. Unable or unwilling to comply with the experimental protocol approved by the researcher.
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 peritoneal dialysis solutionEach subject received treatment with 1 bag of amino acid peritoneal dialysis daily and 2-4 bags of glucose peritoneal dialysis solution daily for 6 months | Drug | Self Control |
Primary outcome
Blood Albumin
Time frame: 6 months
Changes in blood albumin levels
Prealbumin
Time frame: 6 months
Changes in blood prealbumin levels
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40864356Deng S, Xuan H, Chen L, Su X, Su Y, Lu Y, Zhu M, Yang X, Luo C, Shi W. Overnight-dwelled amino acid-based peritoneal dialysis solutions for malnutrition in CAPD: a prospective real-world study. Int Urol Nephrol. 2026 Feb;58(2):661-671. doi: 10.1007/s11255-025-04749-y. Epub 2025 Aug 27.
- Individual participant dataSharing planned: No
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.
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 Amino acid peritoneal dialysis solution in people with Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution, run by The People's Hospital of Gaozhou at 1 site 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 4 inclusion and 5 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 16 Jul 2025. 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 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?
Yes. Results are posted in the registry (first posted 16 Jul 2025). 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?
Blood Albumin (time frame: 6 months). The study lists 2 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 NCT06358820, 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 16 Jul 2025.