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

Peritoneal Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369096
• Other study ID #: FRIAT-BEM-2005-01
• Secondary ID: BEMIDEXTRINAEudr
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2006
• Last updated: May 13, 2010
• Start date: September 2006
• Est. completion date: May 2009

Study information

• Verified date: May 2010
• Source: Fundación Renal Iñigo Alvarez De Toledo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peritoneal Diseases

Intervention

Drug:
• bemiparin 3500 IU/day

Locations

Country	Name	City	State
Spain	Hospital Juan Canajelo	A Coruña
Spain	Hospital Universitario Príncipe de Asturias	Alcala de Henares (Madrid)
Spain	Hospital German Trias i Pujol	Badalona (Barcelona)
Spain	Hospital Clinic de Barcelona	Barcelona	Cataluña
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Dr. Josep Trueta	Gerona	Cataluña
Spain	Complejo hospitalario de Jaen	Jaen
Spain	Hospital Arnau de Vilanova	Lleida
Spain	Fundación Hospital Alcorcón	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Regional Universitario Carlos Haya	Málaga	Andalucia
Spain	Hospital de Orense	Orense	Galicia
Spain	Corporación Sanitaria Parc Tauli	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Renal Iñigo Alvarez De Toledo	Infociencia S.L

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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