Trial Outcomes & Findings for Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution (NCT NCT06358820)
NCT ID: NCT06358820
Last Updated: 2025-07-16
Results Overview
Changes in blood albumin levels
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
149 participants
Primary outcome timeframe
6 months
Results posted on
2025-07-16
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
149
|
|
Overall Study
COMPLETED
|
128
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
kidney transplantation
|
3
|
|
Overall Study
patient voluntary withdrawal
|
6
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution
Baseline characteristics by cohort
| Measure |
Enrolled
n=149 Participants
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.
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|---|---|
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Age, Continuous
|
52.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
149 · Female
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
149 · Male
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
149 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
149 participants
n=5 Participants
|
|
Duration of CAPD（Continuous ambulatory peritoneal dialysis）
|
2.67 years
STANDARD_DEVIATION 1.16 • n=5 Participants
|
|
Residual urine
|
300 ml/day
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Changes in blood albumin levels
Outcome measures
| Measure |
Self Control
n=142 Participants
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
|
|---|---|
|
Blood Albumin
|
4.02 g/L
Standard Deviation 3.64
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Changes in blood prealbumin levels
Outcome measures
| Measure |
Self Control
n=142 Participants
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
|
|---|---|
|
Prealbumin
|
44.23 mg/L
Standard Deviation 81.77
|
Adverse Events
Adverse Event
Serious events: 31 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Adverse Event
n=149 participants at risk
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.
|
|---|---|
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Infections and infestations
Peritonitis
|
11.4%
17/149 • 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
|
|
Infections and infestations
Diabetic foot infection
|
2.7%
4/149 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory system infection
|
2.0%
3/149 • 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
|
|
Surgical and medical procedures
Inguinal hernia
|
2.0%
3/149 • 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
|
|
Gastrointestinal disorders
Gastrointestinal lesions and fatigue
|
1.3%
2/149 • 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
|
|
Infections and infestations
Subcutaneous tunnel infection
|
0.67%
1/149 • 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
|
|
Surgical and medical procedures
Displacement of peritoneal dialysis catheter
|
0.67%
1/149 • 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
|
Other adverse events
| Measure |
Adverse Event
n=149 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.67%
1/149 • 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
|
|
Gastrointestinal disorders
Abdominal distension
|
0.67%
1/149 • 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
|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
0.67%
1/149 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place