Clinical trial NCT06492031: Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Renal Failure
Keywords: Continuous ambulatory peritoneal dialysis
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2024-07-09
Enrollment: 889
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in China prescribed icodextrin or glucose PD solutions for continuous ambulatory peritoneal dialysis.

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.

Detailed description: Patients will be divided into icodextrin dialysate group (ICO group) and glucose dialysate group (glucose group).

ICO group: Patient data will be collected retrospectively and prospectively. Patients currently prescribed icodextrin will be recruited and enrolled. Data for these patients will included both retrospective historical data collection as well as a prospective collection of additional data. Within the relative look-back period (i.e., within 6 months before the launch of the study site), data will be collected from baseline (i.e., the most recent medical records prior to the first prescription of icodextrin) up to signing of the ICF. After providing informed consent, patient data will be prospectively collected for 12 months.

Additionally, any patients who are first prescribed icodextrin therapy after the launch of the study site will also be recruited and enrolled prospectively and data will be collected up to 12 months from enrollment for this group. For these patients, baseline will be defined as the most recent medical record from the time of signing the ICF to the first prescription of icodextrin.

Glucose group: Patient data will be collected retrospectively. Retrospective data will be collected up to 12 months from baseline (i.e., the most recent medical record before the index date, whereby the index date is defined as the date of the first prescription of glucose PD solutions for long dwell exchange between July 1, 2020, and December 31, 2020).

The effectiveness and safety between the 2 groups will be analyzed.

Eligibility criteria: Inclusion Criteria for patients enrolled retrospectively in the ICO Group:

* 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).

Inclusion Criteria for patients enrolled prospectively in the ICO Group:

* 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.

Exclusion Criteria for the ICO Group:

* 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.

Inclusion Criteria for the Glucose Group:

* 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.

Exclusion Criteria for the Glucose Group:

* Those with combined HD within 30 days prior to the index date;
* History of peritonitis within 30 days prior to the index date or presence of acute or chronic exit site infection or tunnel infection during the index period;
* Prescription of non-Baxter PD solutions within 1 month prior to the index date.

Primary outcomes:
measure: Comparison of the incidence of a composite endpoint for technique failure and death
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of the proportion of patients with technique failure
timeFrame: 12 months
measure: Comparison of the incidence of cardiovascular events
timeFrame: 12 months
measure: Comparison of the incidence of the changes in ejection fraction
timeFrame: 12 months
measure: Comparison of all-cause deaths
timeFrame: 12 months
measure: Comparison of medical resource utilization in terms of hospitalizations
timeFrame: 12 months
measure: Comparison of annual exchange dosage of ICO
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Haidian Hospital
city: Hangzhou
country: China
facility: Hangzhou Hospital Of Traditional Chinese Medicine
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
city: Jiangse
country: China
facility: Nanjing Drum Tower Hospital
city: Jiangse
country: China
facility: Wuxi People's Hospital
city: Jiangse
country: China
facility: The First People's Hospital of Kunshan
city: Ningbo
country: China
facility: Ningbo First Hospital
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jaotong University School of Medicine
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
Study officials:
References: