Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597201
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Evaluate the Efficacy and Safety of Amino Acid 15 Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Prospective Open-label Randomized Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Amino Acid 15 Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized parallel controlled Phase IV clinical study to evaluate the safety and efficacy of amino acid 15 peritoneal dialysis solution in patients undergoing peritoneal dialysis with malnutrition in CAPD patients undergoing peritoneal dialysis maintenance
Detailed Description:
After the subjects signed the informed consent they entered the screening period D-28 to D-1 for corresponding examination Participants who were successfully screened were examined at baseline D-3 to D-1 to re-verify the inclusion criteria After re-verification of successful screening subjects they were enrolled in 11 parallel groups according to the research center experimental group treated with amino acid 15 peritoneal dialysate Control group - glucose peritoneal dialysate treatment Subjects were randomly enrolled and given the experimental drug from the next morning according to the randomized results Subjects in the experimental group were treated with 1 bag of amino acid 15 peritoneal dialysate 2L once a day in the morning and were subsequently treated with conventional glucose peritoneal dialysate lactate Control subjects received conventional treatment with glucose peritoneal dialysis solution lactate which must include 15 glucose peritoneal dialysis solution lactate 2L once The number of peritoneal dialysate exchange the amount of fluid exchange and the duration of abdominal retention were adjusted by the researchers according to the specific conditions of the patients Efficacy and safety were observed during the treatment period D1-D90 Blood routine and blood biochemistry were monitored for 30 days 60 days and 90 days of treatment nPNA AMC MAMC SGA BMI KtV etc are monitored only at 90 days The total daily ultrafiltration volume of the patients the experimental group also recorded the ultrafiltration volume of amino acid peritoneal fluid and all adverse events aes and serious adverse events SAEs were recorded in detail
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None