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| Name | Class |
|---|---|
| Renal Solutions, Inc. | INDUSTRY |
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The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Subject will continue conventional hemodialysis therapy for one week ("no intervention" phase) and then swtich to the Allient system for two weeks ("active comparator" phase). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allient System | Device | The Allient System uses a different type of blood pump and a lower volume of dialysate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of specific waste products from blood determined through subject blood and dialysate samples | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation as determined by levels of specific inflammatory markers | 3 weeks | |
| Red blood cell lifespan determined through a measurement of CO in the subject's breath | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan W. Levin, MD | Renal Research Institute | Principal Investigator |
| Peter Kotanko, MD | Renal Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irving Place Dialysis Center | New York | New York | 10003 | United States | ||
| Upper Manhattan Dialysis Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25710773 | Derived | Rosales L, Thijssen S, Kruse A, Sipahioglu MH, Hirachan P, Raimann JG, Kuntsevich V, Carter M, Levin NW, Kotanko P. Inflammatory Response to Sorbent Hemodialysis. ASAIO J. 2015 Jul-Aug;61(4):463-7. doi: 10.1097/MAT.0000000000000212. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 4, 2013 | |
| Reset | Jan 21, 2014 | |
| Release | Feb 18, 2014 | |
| Reset | Apr 1, 2014 | |
| Release | Apr 10, 2017 | |
| Reset | May 17, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 4, 2013 | Jan 21, 2014 | |||
| Feb 18, 2014 |
| 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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| New York |
| New York |
| 10025 |
| United States |
| Yorkville Dialysis Center | New York | New York | 10128 | United States |
| Apr 1, 2014 |
| Apr 10, 2017 | May 17, 2017 |
| 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 |