Efficacy Study of the Addition of Bemiparin to Icodextrin Solution in Peritoneal Dialysis Patients (Bemidextrina)

NCT00369096 | Completed Phase 2 DMC

• 3 other identifiers: FRIAT-BEM-2005-01BEMIDEXTRINAEudraCT:2005-005695-32
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 17

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.

Conditions

Peritoneal Diseases

Keywords

Peritoneal Dialysis; Bemiparin; Icodextrin; Peritoneal Transport Disorders

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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

Interventions

bemiparin 3500 IU/day DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old, of either sex, who have given their informed consent to participate in the study.
• 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).
• Patients in whom the remaining dialyzing liquids used in their PD contain glucose and GDP (glucose degradation products).

You may not qualify if:

• Peritonitis in the past 2 months.
• Major surgery in the past month.
• Known hypersensitivity to low molecular weight heparin (LMWH), heparin or substances of porcine origin.
• Known hypersensitivity to icodextrin.
• Patients treated with systemic anticoagulation.
• Patients with congenital or acquired bleeding diathesis.
• Damage to, or surgical interventions of, the central nervous system, eyes or ears within the past 2 months.
• Acute bacterial endocarditis or slow endocarditis.
• Patients with a history of heparin-associated thrombocytopenia.
• 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).
• Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
• Patients with inability or suspected inability to comply with treatment and/or complete the study.
• Patients who are participating in another clinical trial or have done so in the past 30 days.
• Patients with a life expectancy less than 6 months.
• Women who are pregnant, breast-feeding or fertile women who are not using an effective contraceptive method.

Sponsors & Collaborators

• Fundación Renal Iñigo Alvarez De Toledo: lead
• Infociencia S.L: collaborator

Study Sites (17)

Hospital Regional Universitario Carlos Haya

Málaga, Andalusia, 29010, Spain

Location

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Corporación Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital Dr. Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Hospital de Orense

Ourense, Galicia, 32005, Spain

Location

Complejo hospitalario de Jaen

Jaén, Jaen, 23007, Spain

Location

Hospital Juan Canajelo

A Coruña, 15006, Spain

Location

Hospital Universitario Príncipe de Asturias

Alcala de Henares (Madrid), 28805, Spain

Location

Hospital German Trias i Pujol

Badalona (Barcelona), 08916, Spain

Location

Hospital de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Fundación Hospital Alcorcón

Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Peritoneal Diseases

Interventions

bemiparin

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 28, 2006
• First Posted: August 29, 2006
• Study Start: September 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2009
• Last Updated: May 14, 2010

Record last verified: 2010-05

Locations

ES (17)