Skip to content

A multicenter clinical study of the efficacy and safety of icodextrin peritoneal dialysis solution in improving the volume status of peritoneal dialysis patients

A multicenter clinical study of the efficacy and safety of icodextrin peritoneal dialysis solution in improving the volume status of peritoneal dialysis patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062379
Enrollment
Unknown
Registered
2022-08-03
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease

Interventions

Experimental group: icodextrin peritoneal dialysis solution for nocturnal retention of abdominal dialysis
The control group:2.5% glucose peritoneal dialysis solution for nocturnal retention of abdominal dialysis

Sponsors

First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Sign a written informed notice; 2) 18 years = 90 d (eluting phase); 4) Patients requiring 2-3 daytime fluid changes and 1 nighttime fluid change using 2.5% glucose peritoneal dialysis solution 2.0L with prolonged nighttime abdominal retention (8-10h) every 24h during the 30d prior to the screening visit; 5) Urine output <= 750 ml/d; 6) High transit or high mean transit as judged by peritoneal equilibrium test (PET).

Exclusion criteria

Exclusion criteria: 1) Failure to sign a written informed consent form or inability/unwillingness to comply with the investigator-approved study protocol; 2) Hypersensitivity to corn starch or icodextrin; 3) Patients with maltose or isomaltose intolerance and those with glycogen storage disease; 4) Serious illness or injury within 30d prior to the visit; 5) Acute or chronic peritoneal dialysis tubing outlet or tunnel infection at the time of the visit, or peritonitis requiring antibiotic therapy at the time of the visit or 30d prior to the visit; 6) Having other serious illnesses such as cirrhosis, heart failure, tumors, severe lactic acidosis, etc; 7) Pregnant or lactating women; 8) Being involved in other interventional studies or having participated in other interventional studies in the 3 months prior to enrollment; 9) Having used icodextrin peritoneal dialysis solution or other experimental drugs within 30d prior to the visit; 10) previous history of impairment of peritoneal function or extensive adhesions leading to reduced peritoneal function 11) Patients with a life expectancy of <12 months; 12) Patients whose condition is judged by the investigator to be unsuitable for participation in this pilot study.

Design outcomes

Primary

MeasureTime frame
Volume status;Ultrafiltration volume;

Secondary

MeasureTime frame
Peritoneal solute transport rate;Adequacy of dialysis;Residual renal function;Blood pressure;Survival rate;Technology Survival Rate;Complications;

Countries

China

Contacts

Public ContactZhou Zhu

First Affiliated Hospital of Kunming Medical University

zhouzhu21@163.com+86 13908870859

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026