Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution
Conditions
Keywords
amino acid peritoneal dialysis solution；peritoneal dialysis
Brief 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. 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.
Interventions
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
Sponsors
The People's Hospital of Gaozhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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; 2. Blood urea nitrogen ≤ 38mmol/L; 3. The patient's age is between 18 and 75 years old; 4. The patient signs an informed consent form.
Exclusion criteria
1. Individuals who are allergic to any amino acids or excipients in this product 2. More than one occurrence of peritonitis in the past three months; Peritonitis or hospitalization within the past month; 3. 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; 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Albumin | 6 months | Changes in blood albumin levels |
| Prealbumin | 6 months | Changes in blood prealbumin levels |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 149 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | kidney transplantation | 3 |
| Overall Study | patient voluntary withdrawal | 6 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Enrolled |
|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 10.9 |
| Duration of CAPD（Continuous ambulatory peritoneal dialysis） | 2.67 years STANDARD_DEVIATION 1.16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 149 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 149 participants |
| Residual urine | 300 ml/day |
| Sex: Female, Male 149 Female | 78 Participants |
| Sex: Female, Male 149 Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 149 |
| other Total, other adverse events | 3 / 149 |
| serious Total, serious adverse events | 31 / 149 |
Outcome results
Primary
Blood Albumin
Changes in blood albumin levels
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Control | Blood Albumin | 4.02 g/L | Standard Deviation 3.64 |
Comparison: Outcome Measure were assessed at baseline and every month during the 6-month study.p-value: <0.012595% CI: [3.15, 4.39]ANOVA
Primary
Prealbumin
Changes in blood prealbumin levels
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Control | Prealbumin | 44.23 mg/L | Standard Deviation 81.77 |
p-value: 0.012595% CI: [26.66, 56.87]ANOVA