Patients with end-stage renal disease (ESRD) who have high-average peritoneal transport (as determined by the peritoneal equilibration test, PET) and require continuous ambulatory peritoneal dialysis (CAPD) because non-dialysis therapy has been ineffective.
Conditions
Interventions
Treatment group:Icodextrin Peritoneal Dialysis Solution (Shanghai Changzheng Fumin Jinshan Pharmaceutical Co., Ltd.)
Control group:Icodextrin Peritoneal Dialysis Solution (VANTIVE HEALTHCARE (GUANGZHOU) CO., LTD.)
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years (inclusive), willing to voluntarily participate in this study, and able to sign the informed consent form; 2. Subjects with end-stage renal disease (ESRD) who require continuous ambulatory peritoneal dialysis (CAPD) because non-dialysis therapy has been ineffective; 3. Subjects whose peritoneal transport status is determined as high average (HA) based on the results of the standard peritoneal equilibration test (PET). PET results obtained within 3 months prior to screening at this site are acceptable, provided that no peritonitis occurred during that period; 4. Subjects who, due to failure of non-dialysis therapy, have undergone peritoneal dialysis catheter implantation and have been receiving continuous ambulatory peritoneal dialysis (CAPD) for >=90 days at the screening visit, and have been on continuous dialysis with glucose-based peritoneal dialysis solution for >=30 days (with 2–3 exchanges during the daytime and 1 exchange at night within each 24-hour period, using glucose-based solution for both daytime and nighttime exchanges); 5. Subjects who, based on clinical judgment, have poor ultrafiltration efficacy with glucose-based peritoneal dialysis solution and are considered by the investigator to require switching to icodextrin peritoneal dialysis solution for continued peritoneal dialysis [according to Recommendation 3 of the 2021 International Society for Peritoneal Dialysis (ISPD) guidelines on the assessment of peritoneal membrane dysfunction in adults, poor ultrafiltration can be determined if either of the following two conditions is met: (1) net ultrafiltration volume <400 mL at 4 hours with 4.25% glucose dialysate, or <100 mL at 4 hours with 2.5% glucose dialysate; or (2) the investigator judges that the daily ultrafiltration volume is insufficient to achieve adequate dialysis and maintain volume balance]; 6. Trial participants agree to use effective contraceptive measures from the time of signing the informed consent form through the entire study period until the last visit, and to continue using effective contraception and have no plans for pregnancy within 3 months after the completion of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects who have acute infection, serious illness, or symptoms at the screening visit; or who have acute or chronic dialysis catheter exit-site or tunnel infection; or who have had peritonitis requiring antibiotic therapy within 30 days prior to the screening visit. 2. Subjects who have undergone surgery of Grade II or above (as per the Measures for the Graded Management of Surgical Procedures in Medical Institutions issued by the General Office of the National Health Commission [No. 2022-18]) within 2 months prior to randomization, with reference to the institution's surgical grading management catalogue; or who currently have any indication for surgery; or who are planned to undergo surgery during the study period. 3. Subjects who, in the investigator's assessment, have metabolic acidosis or are at increased risk thereof. 4. Subjects with a history suggestive of maltose or isomaltose intolerance and glycogen storage disease, or with known allergy to corn starch or icodextrin, or with known hypersensitivity to starch-based polymers (e.g., corn starch) or icodextrin. 5. Subjects with uncorrectable mechanical defects that prevent effective peritoneal dialysis (e.g., catheter obstruction, migration, kinking; intestinal obstruction; hernia not surgically repairable; omphalocele; gastroschisis; bladder exstrophy; severe skin disease of the abdominal wall; extensive abdominal wall infection; or extensive abdominal burns). 6. Subjects with diffuse vascular diseases that may impair peritoneal filtration function, such as severe systemic vasculopathy, polyangiitis, severe arteriosclerosis, or scleroderma. 7. Subjects with comorbid conditions that increase the risk of infection (e.g., inflammatory bowel disease, ischemic bowel disease, recurrent diverticulitis, intra-abdominal inflammatory lesions, chronic obstructive pulmonary disease, or those who have undergone abdominal surgery of Grade II or above within 30 days). 8. Subjects with other serious illnesses that, in the investigator's judgment, make them unsuitable for participation in this trial, including but not limited to poorly controlled hypertension, heart failure, pulmonary edema, serous cavity effusion and interstitial fluid retention, giant abdominal tumors, giant polycystic kidneys, cirrhosis, morbid obesity, severe malnutrition, severe intervertebral disc disease, or malignancy not stably controlled. 9. Subjects with other serious concomitant diseases that render them unsuitable for participation in this trial, including but not limited to those affecting the respiratory, circulatory, endocrine, digestive, neurological, or psychiatric systems, as judged by the investigator to be inappropriate for enrollment. 10. Subjects with a history of peritoneal function loss, such as severe peritoneal defects, sclerosing peritonitis, encapsulating peritoneal sclerosis, or extensive adhesions affecting peritoneal function. 11. Women who are pregnant or breastfeeding. 12. Subjects who have participated in other clinical trials of investigational products within 3 months prior to randomization (based on the last visit of the previous trial). 13. Subjects with a history of alcohol abuse upon questioning, or who, within 3 months prior to screening, consume an average of >=14 units of alcohol per week (approximately: 1 unit = 45 mL of high-proof liquor [40-65% alcohol by volume] / 150 mL wine / 350 mL beer), or who are unable to abstain from alcohol during the trial. 14. Subjects who are unable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Net ultrafiltration volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event;Physical examination;Vital signs;Complete blood count;Electrocardiogram (ECG) examination;Urinalysis;Body weight;Acid-base analysis;Peritoneal urea clearance;Net ultrafiltration volume;Peritoneal creatinine clearance rate;Serum hCG test;Infectious disease screening (HIV, HBV, HCV, and syphilis);blood biochemistry; | — |
Countries
China
Contacts
Public ContactZuo Li
Peking University People's Hospital
Outcome results
None listed