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| Name | Class |
|---|---|
| Sequana Medical N.V. | INDUSTRY |
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This study will evaluate the safety and tolerability profile of a dwell time (bath) of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose in patients with chronic kidney failure undergoing peritoneal dialysis
Phase I clinical trial which will include ten patients currently undergoing chronic peritoneal dialysis treatment. Patients will be hospitalized for the study. The study will consist of replacing conventional peritoneal dialysis solution with a sodium-free 500 ml solution with 30% icodextrin and 10% dextrose with a dwell time of 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30% icodextrin and 10% dextrose | Experimental | Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30% icodextrin and 10% dextrose | Drug | Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety defined as the number serious adverse events related to the investigational product | Safety will be described based on the number of serious adverse events that are determined to be related to the investigational product | During the 24 hour dwell |
| Tolerability defined as pain in a scale from 0 to 4 during infusion, dwell, and drain | Description of pain. Pain will be described in a scale from 0 to 4; 0 is no pain, 1 is mild pain, 2 is moderate pain, 3 is severe pain, and 4 is extreme pain. Pain will be assessed during infusion, then hourly during the 24 hour dwell, and during the draining | During the 24 hour dwell |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrafiltration | Total volume ultrafiltration as determined by the mL obtained during the draining after the 24hr dwell | During the 24 hour dwell |
| Sodium excretion with ultrafiltration | Sodium excretion with ultrafiltration will be calculated by multiplying the mL obtained during the draining after the 24hr dwell by the sodium concentration in a sample of peritoneal fluid |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan B Ivey Miranda, MD | Contact | +52 5556276900 | 22209 | betuel.ivey@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Juan B Ivey Miranda, MD | Affiliated to Heart Failure Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de CardiologÃa, Centro Médico Nacional Siglo XXI | Recruiting | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39790231 | Derived | Asher JL, Ivey-Miranda JB, Maulion C, Cox ZL, Borges-Vela JA, Mendoza-Zavala GH, Cigarroa-Lopez JA, Silva-Rueda RI, Revilla-Monsalve C, Moreno-Villagomez J, Ramos-Mastache D, Goedje O, Crosbie I, McIntyre C, Finkelstein F, Turner JM, Testani JM, Rao VS. Development of a Novel Intraperitoneal Icodextrin/Dextrose Solution for Enhanced Sodium Removal. Kidney Med. 2024 Nov 16;7(1):100938. doi: 10.1016/j.xkme.2024.100938. eCollection 2025 Jan. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077607 | Icodextrin |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| During the 24 hour dwell |
| 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 |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |