Status:
RECRUITING
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Chronic Renal Failure
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 28 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
889 Patients enrolled
Trial Details
Trial ID
NCT06492031
Start Date
June 28 2024
End Date
March 1 2026
Last Update
March 18 2025
Active Locations (10)
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1
Beijing Haidian Hospital
Beijing, China, 100000
2
Hangzhou Hospital Of Traditional Chinese Medicine
Hangzhou, China, 310007
3
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China, 010000
4
Nanjing Drum Tower Hospital
Jiangse, China, 210008