Effectiveness and Safety of Icodextrin Peritoneal Dialysis Solution (Extraneal®) for Long Dwell Exchange in Peritoneal Dialysis in Patients With Chronic Renal Failure: a Multicenter, Ambispective Cohort, Observational, Real-world Study

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The purpose of this study is to evaluate the effectiveness and safety of icodextrin and glucose peritoneal dialysis (PD) solutions for the long dwell exchange in PD patients with continuous ambulatory peritoneal dialysis (CAPD), and to describe medical resource utilization in patients with PD on icodextrin.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Age ≥ 18 years old at first prescription of icodextrin, male or female;

• With a definite diagnosis of CRF and on maintenance PD ≥ 3 months;

• On CAPD treatment;

• Being treated with icodextrin long dwell exchange with an icodextrin prescription ≤ 6 months with essential baseline information(including age, gender, PD vintage, presence of diabetes or not, PET, and assessment of dialysis adequacy);

• Voluntarily sign the informed consent form (ICF) and be willing to complete the study visits as required by the investigator (For death cases, exemption of the informed consent will be applied with approval of the ethics committee).

• Age ≥ 18 years old, male or female;

• Patients with a definite diagnosis of CRF and on maintenance PD ≥ 3 months;

• On CAPD treatment, with planned prescription for icodextrin;

• Voluntarily sign the ICF and be willing to complete the study visits as required by the investigator.

• Age ≥ 18 years at index date, male or female;

• Those with a definitive diagnosis of CRF prior to the index date and eligible for CAPD treatment with Baxter's glucose PD solutions between July 1, 2020 and December 31, 2020;

• On maintenance PD ≥ 3 months;

• Essential baseline information(including age, gender, PD vintage, presence of diabetes or not, peritoneal transport status);

• Any prescription of Baxter's glucose PD solutions and medical records of clinical events within 1 year from baseline.

Locations
Other Locations
China
Beijing Haidian Hospital
RECRUITING
Beijing
Hangzhou Hospital Of Traditional Chinese Medicine
RECRUITING
Hangzhou
The Affiliated Hospital of Inner Mongolia Medical University
RECRUITING
Hohhot
Nanjing Drum Tower Hospital
RECRUITING
Jiangse
The First People's Hospital of Kunshan
RECRUITING
Jiangse
Wuxi People's Hospital
RECRUITING
Jiangse
Ningbo First Hospital
RECRUITING
Ningbo
Renji Hospital Shanghai Jaotong University School of Medicine
RECRUITING
Shanghai
Shanghai General Hospital
RECRUITING
Shanghai
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Global CORP Clinical Trials Disclosure
Global.CORP.ClinicalTrialsDisclosure@vantive.com
+1 2249484283
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2026-03
Participants
Target number of participants: 889
Treatments
Icodextrin (ICO) Group
Icodextrin is only intended for intraperitoneal administration and is recommended for long dwell during CAPD (i.e., recommended dwell time from 8-16 hours). Administration will be done at a rate that is comfortable for the patient, typically within 10-20 minutes.
Glucose Group
During CAPD, 2L of dialysis fluid is instilled into the peritoneal cavity and allowed to dwell for a certain period. The dwell time typically ranges from 4 to 8 hours during the day and 8 to 12 hours at night. This process is repeated 3 to 4 times a day, for 6 to 7 days a week. The frequency of solution exchanges may vary for each individual to achieve desired biochemical and solution control. Most solution exchanges utilize a 1.5% or 2.5% glucose dialysis solution. If more solution removal is required, a 4.25% glucose peritoneal dialysis solution can be used. Regular measurement of the patient's weight can be used to guide the setting of ultrafiltration volume.
Related Therapeutic Areas
Sponsors
Leads: Vantive Health LLC
Collaborators: Baxter Healthcare Corporation

This content was sourced from clinicaltrials.gov