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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the incidence of a composite endpoint for technique failure and death | Technique failure is defined as:
Death is specified as deaths during PD or deaths within 30 days with treatment from PD to HD/PHD | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the proportion of patients with technique failure | Number and proportion of patients with technique failure | 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. |
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Inclusion Criteria for patients enrolled retrospectively in the ICO Group:
Inclusion Criteria for patients enrolled prospectively in the ICO Group:
Exclusion Criteria for the ICO Group:
Inclusion Criteria for the Glucose Group:
Exclusion Criteria for the Glucose Group:
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Patients in China prescribed icodextrin or glucose PD solutions for continuous ambulatory peritoneal dialysis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Haidian Hospital | Beijing | 100000 | China | |||
| Hangzhou Hospital Of Traditional Chinese Medicine |
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).
Upon approval of a legitimate research request.
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.
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077607 | Icodextrin |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| 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. |
|
| 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) | 12 months |
| Comparison of all-cause deaths | All-cause deaths refer to the total number of deaths from any cause within the study timeframe | 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 | 12 months |
| Comparison of annual exchange dosage of ICO | For ICO group only | 12 months |
| Hangzhou |
| 310007 |
| China |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | 010000 | China |
| Nanjing Drum Tower Hospital | Jiangse | 210008 | China |
| Wuxi People's Hospital | Jiangse | 214023 | China |
| The First People's Hospital of Kunshan | Jiangse | 215300 | China |
| Ningbo First Hospital | Ningbo | 315000 | China |
| Shanghai General Hospital | Shanghai | 200080 | China |
| Renji Hospital Shanghai Jaotong University School of Medicine | Shanghai | 200120 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | 215004 | China |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |