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

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

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Diseases
• Intervention / Treatment: Drug: bemiparin 3500 IU/day

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.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Hospital Juan Canajelo
  • Alcala de Henares (Madrid), Spain, 28805
    • Hospital Universitario Príncipe de Asturias
  • Badalona (Barcelona), Spain, 08916
    • Hospital German Trias i Pujol
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08907
    • Hospital De Bellvitge
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen
  • Lleida, Spain, 25198
    • Hospital Arnau de Vilanova
  • Madrid, Spain, 28006
    • Hospital Universitario La Princesa
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28922
    • Fundacion Hospital Alcorcon
  • Madrid, Spain, 28007
    • Hospital Gregorio Marañón
  • Andalucia
    • Málaga, Andalucia, Spain, 29010
      • Hospital Regional Universitario Carlos Haya
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacion Sanitaria Parc Tauli
  • Cataluña
    • Barcelona, Cataluña, Spain, 08036
      • Hospital Clínic de Barcelona
    • Gerona, Cataluña, Spain, 17007
      • Hospital Dr. Josep Trueta
  • Galicia
    • Orense, Galicia, Spain, 32005
      • Hospital de Orense

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Fundación Renal Iñigo Alvarez De Toledo
• Collaborators: Infociencia S.L
• Investigators: Principal Investigator: 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)

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: August 28, 2006
• First Submitted That Met QC Criteria: August 28, 2006
• First Posted (Estimate): August 29, 2006

Study Record Updates

• Last Update Posted (Estimate): May 14, 2010
• Last Update Submitted That Met QC Criteria: May 13, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Bemiparin; Peritoneal Dialysis; Icodextrin; Peritoneal Transport Disorders
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Anticoagulants; Bemiparin
• Other Study ID Numbers: FRIAT-BEM-2005-01; BEMIDEXTRINA; EudraCT:2005-005695-32