Chronic Renal FailureoSCARNCT06492031
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
An observational study of Chronic Renal Failure, run by Vantive Health LLC at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Icodextrin Peritoneal Dialysis Solution and Glucose Peritoneal Dialysis Solution
- How many people
- 439 participants
- Where
- 10 sitesChina
- Study dates
- 28 Jun 2024to 27 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in China prescribed icodextrin or glucose PD solutions for continuous ambulatory peritoneal dialysis.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Beijing Haidian Hospital
Beijing, 100000
Hangzhou Hospital Of Traditional Chinese Medicine
Hangzhou, 310007
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, 010000
Nanjing Drum Tower Hospital
Jiangse, 210008
Wuxi People's Hospital
Jiangse, 214023
The First People's Hospital of Kunshan
Jiangse, 215300
Ningbo First Hospital
Ningbo, 315000
Shanghai General Hospital
Shanghai, 200080
Renji Hospital Shanghai Jaotong University School of Medicine
Shanghai, 200120
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
About this study
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
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.
Read the 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 from CAPD patients followed up in the peritoneal dialysis center from July 1, 2018, to December 31, 2018. Retrospective data will be collected up to 12 months from baseline (i.e., the most recent peritoneal equilibration test date before December 31, 2018, in the peritoneal dialysis center).
The effectiveness and safety between the 2 groups will be analyzed.
- Conditions
- Chronic Renal Failure
- Being tested
- Icodextrin Peritoneal Dialysis Solution, Glucose Peritoneal Dialysis Solution
- Keywords
- Continuous ambulatory peritoneal dialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icodextrin Peritoneal Dialysis SolutionDrug
Also called Extraneal
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.
Glucose Peritoneal Dialysis SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Glucose Peritoneal Dialysis Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (6)
Comparison of the proportion of patients with technique failure
Number and proportion of patients with technique failure
Measured: 12 months
Comparison of the incidence of cardiovascular events
Cardiovascular events include acute myocardial infarction, sudden severe arrhythmia ( a trial fibrillation and arrhythmia requiring hospitalization or medication), hospitalization for heart failure, stroke, and cardiovascular death.
Measured: 12 months
Comparison of the incidence of the changes in ejection fraction
Change of the echocardiographic values from baseline: left ventricular ejection fraction fraction (LVEF）
Measured: 12 months
Comparison of all-cause deaths
All-cause deaths refer to the total number of deaths from any cause within the study timeframe
Measured: 12 months
Comparison of medical resource utilization in terms of hospitalizations
Excluding hospitalizations due to medicare payments or other non-medical issues. For ICO group only
Measured: 12 months
Comparison of annual exchange dosage of ICO
For ICO group only
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start28 Jun 2024
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492031
- Sponsor's protocol ID
- BXU599284
- Acronym
- oSCAR
- Status last verified
- Apr 2026
- First submitted
- 25 Jun 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The Sponsor is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, the Sponsor will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP).
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06492031
- Acronym / sponsor ID
- oSCAR / BXU599284
- Conditions
- Chronic Renal Failure
- Keywords
- Continuous ambulatory peritoneal dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 from CAPD patients followed up in the peritoneal dialysis center from July 1, 2018, to December 31, 2018. Retrospective data will be collected up to 12 months from baseline (i.e., the most recent peritoneal equilibration test date before December 31, 2018, in the peritoneal dialysis center).
The effectiveness and safety between the 2 groups will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icodextrin (ICO) Group | – | Drug: Icodextrin Peritoneal Dialysis SolutionIcodextrin 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 | – | Drug: Glucose Peritoneal Dialysis SolutionDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in China prescribed icodextrin or glucose PD solutions for continuous ambulatory peritoneal dialysis.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Icodextrin Peritoneal Dialysis SolutionAlso: ExtranealThe 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. | Drug | Icodextrin (ICO) Group |
| Glucose Peritoneal Dialysis SolutionThe 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. | Drug | Glucose Group |
Primary outcome
Comparison of the incidence of a composite endpoint for technique failure and death
Time frame: 12 months
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
6 secondary outcomes
Comparison of the proportion of patients with technique failure
Time frame: 12 months
Comparison of the incidence of cardiovascular events
Time frame: 12 months
Comparison of the incidence of the changes in ejection fraction
Time frame: 12 months
Comparison of all-cause deaths
Time frame: 12 months
Comparison of medical resource utilization in terms of hospitalizations
Time frame: 12 months
Comparison of annual exchange dosage of ICO
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Yes. The Sponsor is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, the Sponsor will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Failure, run by Vantive Health LLC at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the incidence of a composite endpoint for technique failure and death (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.