Clinical trial NCT00369096: Efficacy Study of the Addition of Bemiparin to Icodextrin Solution in Peritoneal Dialysis Patients (Bemidextrina)
Official title: Randomized, Controlled and Open Study to Assess the Efficacy (Peritoneal Biocompatibility) of the Addition of Bemiparin to Icodextrin Solution in Patients in Peritoneal Dialysis With Peritoneal Transport Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peritoneal Diseases
Keywords: Peritoneal Dialysis
Bemiparin
Icodextrin
Peritoneal Transport Disorders
Lead sponsor: Fundación Renal Iñigo Alvarez De Toledo
Sponsor class: OTHER
Collaborators: name: Infociencia S.L
First posted: 2006-08-29
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years old, of either sex, who have given their informed consent to participate in the study.
2. Patients in stable treatment with peritoneal dialysis for more than 6 weeks who present peritoneal dysfunction defined by capacity for standardized ultrafiltration (3.86% glucose maintained in the peritoneum for 4 hours) less than 600 ml and/or elevated creatinine transport (defined by D/P of creatinine higher than 0.65 after 4 hours).
3. Patients treated with icodextrin solution for peritoneal dialysis for at least one month before their inclusion.
4. Patients in whom the remaining dialyzing liquids used in their PD contain glucose and GDP (glucose degradation products).

Exclusion Criteria:

1. Peritonitis in the past 2 months.
2. Patients with bleeding at the time of inclusion, or patients with a history of clinically evident bleeding episodes and/or with increased bleeding due to any other homeostatic alteration that contradicts anticoagulant treatment and/or in the past two months have presented at least one of the following situations: active hemorrhaging or organic lesions susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular accident, or aneurysms).
3. Major surgery in the past month.
4. Known hypersensitivity to low molecular weight heparin (LMWH), heparin or substances of porcine origin.
5. Known hypersensitivity to icodextrin.
6. Patients treated with systemic anticoagulation.
7. Patients with congenital or acquired bleeding diathesis.
8. Damage to, or surgical interventions of, the central nervous system, eyes or ears within the past 2 months.
9. Acute bacterial endocarditis or slow endocarditis.
10. Patients with a history of heparin-associated thrombocytopenia.
11. Patients with hepatic insufficiency (with values of AST and/or ALT \> 5 times the normal value established in the reference range of the local hospital laboratory).
12. Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
13. Patients with inability or suspected inability to comply with treatment and/or complete the study.
14. Patients who are participating in another clinical trial or have done so in the past 30 days.
15. Patients with a life expectancy less than 6 months.
16. Women who are pregnant, breast-feeding or fertile women who are not using an effective contraceptive method.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
state: Andalucia
city: Sabadell
country: Spain
facility: Corporación Sanitaria Parc Tauli
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
state: Cataluña
city: Gerona
country: Spain
facility: Hospital Dr. Josep Trueta
state: Cataluña
city: Orense
country: Spain
facility: Hospital de Orense
state: Galicia
city: A Coruña
country: Spain
facility: Hospital Juan Canajelo
city: Alcala de Henares (Madrid)
country: Spain
facility: Hospital Universitario Príncipe de Asturias
city: Badalona (Barcelona)
country: Spain
facility: Hospital German Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Jaen
country: Spain
facility: Complejo hospitalario de Jaen
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Fundación Hospital Alcorcón
Study officials:
affiliation: Hospital Universitario La Paz
name: Rafael Selgas Gutierrez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrología del Hospital Universitario La Paz (Madrid-Spain)
name: Mª Auxiliadora Bajo Rubio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrología del Hospital Universitario La Paz (Madrid - Spain)
name: Dra. Gloria del Peso Gilsanz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Universitario La Princesa (Madrid-Spain)
name: Antonio Carlos Fernández Perpén, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Universitario Príncipe de Asturias de Alcala de Henares (Madrid - Spain)
name: Mercedes L. Velo Plaza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Juan Canalejo (La Coruña - Spain)
name: Miguel Pérez Fontán, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Universitario Ramón y Cajal (Madrid - Spain)
name: Maite Rivera Gorrín, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Universitario Ramón y Cajal (Madrid - Spain)
name: MªTeresa Tenorio Cañamas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrología de la Fundación Hospital de Alcorcón (Madrid - Spain)
name: José Portolés Pérez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Gregorio Marañón (Madrid - Spain)
name: Juan Manuel López Gómez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital German Trias i Pujol de Badalona (Barcelona-Spain)
name: Josep Teixidó, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Arnau de Vilanova (Lleida - Spain)
name: Mercé Borras, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrología del Hospital de Orense(Galicia-Spain)
name: Cristina Pérez Melon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Regional Universitario Carlos Haya (Málaga-Spain)
name: Silvia Ros Ruíz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrología del Hospital de Bellvitge (Barcelona-Spain)
name: Teresa González Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Vall d'Hebron (Barcelona - Spain)
name: Jorge Bartolome, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrología de la Corporación Sanitaria Parc Taulí (Barcelona - Spain)
name: Esther Ponz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Josep Trueta (Gerona - Spain)
name: Pere Torguet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrologia del Hospital Clinic de Barcelona (Barcelona - Spain)
name: Manel Vera i Rivera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrología del Hospital Lluis Alcanyis Xátiva (Valencia - Spain)
name: Juan Carlos Alonso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Nefrología del Complejo Hospitalario de Jaen (Jaen - Spain)
name: Jose Manuel Gil, MD
role: PRINCIPAL_INVESTIGATOR
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