Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients

NCT06492031 | Completed

• 1 other identifier: BXU599284
• Study Type: observational
• Target: 439
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Chronic Renal Failure

Keywords

Continuous ambulatory peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• Comparison of the incidence of a composite endpoint for technique failure and death

  Technique failure is defined as: * Treatment transferred from PD to HD/PHD \> 30 days; or * PHD, defined as adding HD treatment at least once every 2 weeks in 30 days during PD and requiring long-term combined HD as determined by the investigator. Death is specified as deaths during PD or deaths within 30 days with treatment from PD to HD/PHD

  12 months

Secondary Outcomes (6)

• Comparison of the proportion of patients with technique failure

  12 months

• Comparison of the incidence of cardiovascular events

  12 months

• Comparison of the incidence of the changes in ejection fraction

  12 months

• Comparison of all-cause deaths

  12 months

• Comparison of medical resource utilization in terms of hospitalizations

  12 months

Study Arms (2)

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.

Drug: Icodextrin Peritoneal Dialysis Solution

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.

Drug: Glucose Peritoneal Dialysis Solution

Interventions

Icodextrin Peritoneal Dialysis Solution DRUG

The treatment modality, treatment frequency, treatment dose, duration of dwell, and length of treatment, as determined and supervised by a prescribing physician experienced in treating ESRD with PD.

Also known as: Extraneal

Icodextrin (ICO) Group

Glucose Peritoneal Dialysis Solution DRUG

The treatment modality, number of daily dialysate exchanges, dialysate concentration, exchange dosage of dialysate, duration of dwell, and length of treatment for PD patients as determined by the clinician.

Glucose Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in China prescribed icodextrin or glucose PD solutions for continuous ambulatory peritoneal dialysis.

You may qualify if:

• 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.

You may not qualify if:

• Those with combined HD within 30 days prior to enrolment;
• History of peritonitis within 30 days prior to enrolment or presence of acute or chronic exit site infection or tunnel infection at enrolment;
• Participation in another interventional study within 30 days prior to enrolment or concurrently with this study;
• Allergy to any components of Icodextrin;
• Pregnancy or in lactation;
• Any other condition for which the investigator considers the patient to be unsuitable for participation in this study.
• Age ≥ 18 years at baseline, male or female;
• Those with a definitive diagnosis of CRF prior to baseline and eligible for CAPD treatment with Baxter's glucose PD solutions between July 1, 2018 and December 31, 2018;
• On maintenance PD ≥ 3 months;
• Essential baseline information (including age, gender, PD vintage, presence of diabetes or not, peritoneal transport status, dialysis adequacy assessment, 24-hour urine volume);
• Any prescription of Baxter's glucose PD solutions and medical records of clinical events within 1 year from baseline.
• Those with combined HD within 30 days prior to baseline;
• History of peritonitis within 30 days prior to baseline or presence of acute or chronic exit site infection or tunnel infection during baseline;
• Prescription of non-Baxter PD solutions within 1 month prior to baseline.
• Patients enrolled in the ICO group.

Sponsors & Collaborators

• Vantive Health LLC: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (10)

Beijing Haidian Hospital

Beijing, 100000, China

Location

Hangzhou Hospital Of Traditional Chinese Medicine

Hangzhou, 310007, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, 010000, China

Location

Nanjing Drum Tower Hospital

Jiangse, 210008, China

Location

Wuxi People's Hospital

Jiangse, 214023, China

Location

The First People's Hospital of Kunshan

Jiangse, 215300, China

Location

Ningbo First Hospital

Ningbo, 315000, China

Location

Shanghai General Hospital

Shanghai, 200080, China

Location

Renji Hospital Shanghai Jaotong University School of Medicine

Shanghai, 200120, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, 215004, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Icodextrin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 9, 2024
• Study Start: June 28, 2024
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon approval of a legitimate research request.
• Access Criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If the Sponsor agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of the Sponsor prior to the release of any data.

Locations

CN (10)