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New treatment option for Peritoneal Dialysis
Official title Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients
ClinicalTrials.gov ID: NCT07077538
What this study is testing
What is Amino acid peritoneal dialysis solution?
Amino acid peritoneal dialysis solution is an investigational medicine, given as an once-daily, being studied as a potential treatment for peritoneal dialysis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is a single center, open, prospective, self controlled clinical study. The patients with diabetes who are to be enrolled in peritoneal dialysis are to observe the changes of glycosylated hemoglobin relative to the baseline 90 days after using amino acid (15) peritoneal dialysis solution.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Type I or II diabetes patients aged 18 to 75 years (including 18 and 75 years), regardless of gender;
- Stable peritoneal dialysis patients who have undergone peritoneal dialysis treatment for ≥ 3 months;
- Use 3-5 bags of peritoneal dialysis solution daily;
- 6.0%\<glycated hemoglobin (HbA1c) level ≤ 8.5%;
- 90g/L ≤ Hemoglobin concentration ≤ 130g/L
You likely can't join if
- Peritonitis has occurred within the past 3 months;
- Use Acodextrin peritoneal dialysis solution;
- Contraindications for the presence of amino acids (15) in peritoneal dialysis fluid:
- Individuals allergic to any component of amino acid (15) peritoneal dialysis fluid;
- Serum urea level\>38 mmol/l;
- Metabolic acidosis (CO2 binding capacity\<22mmol/L);
See the full eligibility criteria
- Type I or II diabetes patients aged 18 to 75 years (including 18 and 75 years), regardless of gender;
- Stable peritoneal dialysis patients who have undergone peritoneal dialysis treatment for ≥ 3 months;
- Use 3-5 bags of peritoneal dialysis solution daily;
- 6.0%\<glycated hemoglobin (HbA1c) level ≤ 8.5%;
- 90g/L ≤ Hemoglobin concentration ≤ 130g/L
- Stable use of erythropoietin and rosuvastatin;
- The fluctuation of carbohydrate energy supply ratio in the first 3 months before enrollment is less than 15%;
- Not using amino acid (15) peritoneal dialysis solution for the first 3 months before enrollment;
- Within the past month, the patient's prescription for hypoglycemic drugs has not been adjusted;
- Within the past month, the patient's dietary structure and food intake have remained stable.
- Peritonitis has occurred within the past 3 months;
- Use Acodextrin peritoneal dialysis solution;
- Contraindications for the presence of amino acids (15) in peritoneal dialysis fluid:
- Individuals allergic to any component of amino acid (15) peritoneal dialysis fluid;
- Serum urea level\>38 mmol/l;
- Metabolic acidosis (CO2 binding capacity\<22mmol/L);
- Severe hypokalemia (blood potassium\<2.5mmol/L);
- Various congenital amino acid metabolism abnormalities;
- Liver dysfunction (alanine aminotransferase levels exceeding 2.5 times the upper limit of normal);
- Combined hemoglobinopathies: such as thalassemia, sickle cell disease, etc;
- It is expected that kidney transplantation may be accepted during the trial period;
- Participated in other clinical studies.
The study team makes the final eligibility decision.
Where it's taking place
- Gaozhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gaozhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.