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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self Control | Other | Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino acid peritoneal dialysis solution | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Albumin | Changes in blood albumin levels | 6 months |
| Prealbumin | Changes in blood prealbumin levels | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaozhou People's Hospital | Gaozhou | Guangdong | 525200 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40864356 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Self Control | Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment. Amino acid peritoneal dialysis solution: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled | Patients who completed one efficacy evaluation were defined as having completed the study.149 patients were enrolled, with 142 patients undergoing at least one efficacy evaluation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Albumin | Changes in blood albumin levels | All included subjects received at least 1 dose of study treatment and had data for efficacy evaluation at at least 1 post-treatment observation time point. | Posted | Mean | Standard Deviation | g/L | 6 months |
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From the beginning to the end of the study, the time span is from December 2023 to January 2025.Follow up with each subject for 6 months and record adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Event | Adverse Event (AE) refers to any harmful medical event that occurs during a clinical trial, regardless of whether it is causally related to the investigational drug. Adverse events include the following situations: Adverse Reaction (AR) related to the investigational drug: refers to any harmful medical event caused by the pharmacological effects or other reasons of the investigational drug under normal usage conditions. Adverse events unrelated to the investigational drug: Refers to any harmful medical event that occurs during a clinical trial, but is scientifically determined to have no causal relationship with the investigational drug. Serious Adverse Event (SAE): refers to any harmful medical event that occurs during a clinical trial, regardless of whether it is causally related to the investigational drug, resulting in one of the following consequences: Causing death; Endangering life (i.e., if not intervened in a timely manner, it may lead to death); Need for hospitalization or extended hospitalization; Causing persistent or significant disability or functional impairment; Causing congenital malformations or birth defects; Significant medical interventions (such as surgery, blood transfusions, etc.) are required. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shanshan Deng | Gaozhou People's Hospital | 13927596600 | 276531255@qq.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2023 | May 13, 2025 | Prot_SAP_000.pdf |
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| Physician Decision |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Duration of CAPD(Continuous ambulatory peritoneal dialysis) | Mean | Standard Deviation | years |
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| Residual urine | Median | Inter-Quartile Range | ml/day |
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| Participants |
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| Primary | Prealbumin | Changes in blood prealbumin levels | All included subjects received at least 1 dose of study treatment and had data for efficacy evaluation at at least 1 post-treatment observation time point. | Posted | Mean | Standard Deviation | mg/L | 6 months |
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| 1 |
| 149 |
| 31 |
| 149 |
| 3 |
| 149 |
| Diabetic foot infection | Infections and infestations | Systematic Assessment |
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| Respiratory system infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Inguinal hernia | Surgical and medical procedures | Systematic Assessment |
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| Gastrointestinal lesions and fatigue | Gastrointestinal disorders | Systematic Assessment |
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| Subcutaneous tunnel infection | Infections and infestations | Systematic Assessment |
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| Displacement of peritoneal dialysis catheter | Surgical and medical procedures | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Allergic reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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