Peritoneal DiseasesPhase 2NCT00369096
Efficacy Study of the Addition of Bemiparin to Icodextrin Solution in Peritoneal Dialysis Patients (Bemidextrina)
A Phase 2 study testing bemiparin 3500 IU/day in people with Peritoneal Diseases, run by Fundación Renal Iñigo Alvarez De Toledo at 17 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Diseases
- What is being tested?
- bemiparin 3500 IU/day
- How many people
- 76 participants
- Where
- 17 sitesSpain
- Study dates
- Sep 2006to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 treated with icodextrin solution for peritoneal dialysis for at least one month before their inclusion.
- Patients in whom the remaining dialyzing liquids used in their PD contain glucose and GDP (glucose degradation products).
Who cannot join
- Peritonitis in the past 2 months.
- 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).
- 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.
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Hospital Juan Canajelo
A Coruña, 15006
Hospital Universitario Príncipe de Asturias
Alcala de Henares (Madrid), 28805
Hospital German Trias i Pujol
Badalona (Barcelona), 08916
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, Catalonia, 08036
Hospital de Bellvitge
Barcelona, 08907
Hospital Dr. Josep Trueta
Girona, Catalonia, 17007
Complejo hospitalario de Jaen
Jaén, Jaen, 23007
Hospital Arnau de Vilanova
Lleida, 25198
Hospital Universitario La Princesa
Madrid, 28006
Hospital Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
Fundación Hospital Alcorcón
Madrid, 28922
Hospital Regional Universitario Carlos Haya
Málaga, Andalusia, 29010
Hospital de Orense
Ourense, Galicia, 32005
Corporación Sanitaria Parc Tauli
Sabadell, Barcelona, 08208
About this study
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
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.
Read the 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.
- Conditions
- Peritoneal Diseases
- Being tested
- bemiparin 3500 IU/day
- Keywords
- Peritoneal Dialysis, Bemiparin, Icodextrin, Peritoneal Transport Disorders
- Medical subject headings
- Peritoneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bemiparin 3500 IU/dayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionNov 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Renal Iñigo Alvarez De Toledo
- Sponsor type
- University, hospital or other
- Collaborators
- Infociencia S.L
- Investigators
- Rafael Selgas Gutierrez, MD, Principal investigator, Hospital Universitario La PazMª Auxiliadora Bajo Rubio, MD, Principal investigator, Servicio de Nefrología del Hospital Universitario La Paz (Madrid-Spain)Dra. Gloria del Peso Gilsanz, MD, Principal investigator, Servicio de Nefrología del Hospital Universitario La Paz (Madrid - Spain)Antonio Carlos Fernández Perpén, MD, Principal investigator, Servicio de Nefrologia del Hospital Universitario La Princesa (Madrid-Spain)Mercedes L. Velo Plaza, MD, Principal investigator, Servicio de Nefrologia del Hospital Universitario Príncipe de Asturias de Alcala de Henares (Madrid - Spain)Miguel Pérez Fontán, MD, Principal investigator, Servicio de Nefrologia del Hospital Juan Canalejo (La Coruña - Spain)Maite Rivera Gorrín, MD, Principal investigator, Servicio de Nefrologia del Hospital Universitario Ramón y Cajal (Madrid - Spain)MªTeresa Tenorio Cañamas, MD, Principal investigator, Servicio de Nefrologia del Hospital Universitario Ramón y Cajal (Madrid - Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369096
- Sponsor's protocol ID
- FRIAT-BEM-2005-01
- Other IDs
- BEMIDEXTRINA, EudraCT:2005-005695-32
- Status last verified
- May 2010
- First submitted
- 28 Aug 2006
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00369096
- Acronym / sponsor ID
- FRIAT-BEM-2005-01
- Conditions
- Peritoneal Diseases
- Keywords
- Peritoneal Dialysis, Bemiparin, Icodextrin, Peritoneal Transport Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Fundación Renal Iñigo Alvarez De ToledoUniversity, hospital or other
- Collaborators
- Infociencia S.L
- Study start
- Sep 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 29 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 treated with icodextrin solution for peritoneal dialysis for at least one month before their inclusion.
- Patients in whom the remaining dialyzing liquids used in their PD contain glucose and GDP (glucose degradation products).
Key exclusion criteria (16 listed)
- Peritonitis in the past 2 months.
- 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).
- Major surgery in the past month.
- Known hypersensitivity to low molecular weight heparin (LMWH), heparin or substances of porcine origin.
- Known hypersensitivity to icodextrin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bemiparin 3500 IU/day | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2010.
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Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Selgas Gutierrez, MD principal investigator
Hospital Universitario La Paz
Mª Auxiliadora Bajo Rubio, MD principal investigator
Servicio de Nefrología del Hospital Universitario La Paz (Madrid-Spain)
Dra. Gloria del Peso Gilsanz, MD principal investigator
Servicio de Nefrología del Hospital Universitario La Paz (Madrid - Spain)
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bemiparin 3500 IU/day in people with Peritoneal Diseases, run by Fundación Renal Iñigo Alvarez De Toledo at 17 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2010; AzTrials last refreshed its copy on 6 Nov 2026.