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| ID | Type | Description | Link |
|---|---|---|---|
| BEMIDEXTRINA | |||
| EudraCT:2005-005695-32 |
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| Name | Class |
|---|---|
| Infociencia S.L | INDUSTRY |
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The purpose of this study is to evaluate whether addition of bemiparin, once daily in icodextrin solution for peritoneal dialysis for 16 weeks, increases the peritoneal capacity for ultrafiltration and/or reduces creatinine transport in peritoneal dialysis patients presenting functional disorders related to ultrafiltration deficit and/or high transport.
Peritoneal dysfunction is a common complication in patients in stable treatment with peritoneal dialysis. This peritoneal dysfunction is defined by an elevated creatinine transport and lowered standardized ultrafiltration capacity. The aim of this study is to evaluate the efficacy of the addition of bemiparin to icodextrin solution in patients in peritoneal dialysis with peritoneal transport disorders. The eligible patients are randomly assigned to receive the icodextrin solution with bemiparin or icodextrin solution without bemiparin.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bemiparin 3500 IU/day | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Peritoneal function defined according to the standardized ultrafiltration capacity and/or estimated peritoneal creatinine transport estimated by D/P and mass transfer coefficient during randomized treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of peritonitis during the randomized treatment period, defined by a cell count of peritoneal effluent with more than 100 leukocytes per mm3 with 50% or more polymorphonuclear cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Selgas Gutierrez, MD | Hospital Universitario La Paz | Principal Investigator |
| Mª Auxiliadora Bajo Rubio, MD | Servicio de Nefrología del Hospital Universitario La Paz (Madrid-Spain) | Principal Investigator |
| Dra. Gloria del Peso Gilsanz, MD | Servicio de Nefrología del Hospital Universitario La Paz (Madrid - Spain) | Principal Investigator |
| Antonio Carlos Fernández Perpén, MD | Servicio de Nefrologia del Hospital Universitario La Princesa (Madrid-Spain) | Principal Investigator |
| Mercedes L. Velo Plaza, MD | Servicio de Nefrologia del Hospital Universitario Príncipe de Asturias de Alcala de Henares (Madrid - Spain) | Principal Investigator |
| Miguel Pérez Fontán, MD | Servicio de Nefrologia del Hospital Juan Canalejo (La Coruña - Spain) | Principal Investigator |
| Maite Rivera Gorrín, MD | Servicio de Nefrologia del Hospital Universitario Ramón y Cajal (Madrid - Spain) | Principal Investigator |
| MªTeresa Tenorio Cañamas, MD | Servicio de Nefrologia del Hospital Universitario Ramón y Cajal (Madrid - Spain) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Universitario Carlos Haya | Málaga | Andalusia | 29010 | Spain | ||
| Hospital Vall d'Hebron |
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| José Portolés Pérez, MD | Servicio de Nefrología de la Fundación Hospital de Alcorcón (Madrid - Spain) | Principal Investigator |
| Juan Manuel López Gómez, MD | Servicio de Nefrologia del Hospital Gregorio Marañón (Madrid - Spain) | Principal Investigator |
| Josep Teixidó, MD | Servicio de Nefrologia del Hospital German Trias i Pujol de Badalona (Barcelona-Spain) | Principal Investigator |
| Mercé Borras, MD | Servicio de Nefrologia del Hospital Arnau de Vilanova (Lleida - Spain) | Principal Investigator |
| Cristina Pérez Melon, MD | Servicio de Nefrología del Hospital de Orense(Galicia-Spain) | Principal Investigator |
| Silvia Ros Ruíz, MD | Servicio de Nefrologia del Hospital Regional Universitario Carlos Haya (Málaga-Spain) | Principal Investigator |
| Teresa González Alvarez, MD | Servicio de Nefrología del Hospital de Bellvitge (Barcelona-Spain) | Principal Investigator |
| Jorge Bartolome, MD | Servicio de Nefrologia del Hospital Vall d'Hebron (Barcelona - Spain) | Principal Investigator |
| Esther Ponz, MD | Servicio de Nefrología de la Corporación Sanitaria Parc Taulí (Barcelona - Spain) | Principal Investigator |
| Pere Torguet, MD | Servicio de Nefrologia del Hospital Josep Trueta (Gerona - Spain) | Principal Investigator |
| Manel Vera i Rivera, MD | Servicio de Nefrologia del Hospital Clinic de Barcelona (Barcelona - Spain) | Principal Investigator |
| Juan Carlos Alonso, MD | Servicio de Nefrología del Hospital Lluis Alcanyis Xátiva (Valencia - Spain) | Principal Investigator |
| Jose Manuel Gil, MD | Servicio de Nefrología del Complejo Hospitalario de Jaen (Jaen - Spain) | Principal Investigator |
| Barcelona |
| Barcelona |
| 08035 |
| Spain |
| Corporación Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Hospital Clinic de Barcelona | Barcelona | Catalonia | 08036 | Spain |
| Hospital Dr. Josep Trueta | Girona | Catalonia | 17007 | Spain |
| Hospital de Orense | Ourense | Galicia | 32005 | Spain |
| Complejo hospitalario de Jaen | Jaén | Jaen | 23007 | Spain |
| Hospital Juan Canajelo | A Coruña | 15006 | Spain |
| Hospital Universitario Príncipe de Asturias | Alcala de Henares (Madrid) | 28805 | Spain |
| Hospital German Trias i Pujol | Badalona (Barcelona) | 08916 | Spain |
| Hospital de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Fundación Hospital Alcorcón | Madrid | 28922 | Spain |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C411345 | bemiparin |
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