Renal DialysisNCT01092455
Multi-center Study to Investigate the Effects of Citrasate® on Heparin N Requirements During Hemodialysis Treatment
An observational study of Renal Dialysis, run by Randolph Quinn at 8 sites in United States.
Trial summary
The purpose of this study is to determine whether the use of Citrasate®, citric acid dialysate enables the reduction of the heparin N (anticoagulant) dose in patients undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Heparin N reduction
- How many people
- 300 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2009to Oct 2010
- Phase
- Observational
- 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
Study population: Subjects will be recruited from the hemodialysis population in the participating facilities (study sites).
Who may be able to join
- Subject is capable of giving informed consent, or has an acceptable surrogate capable of giving consent on the subject's behalf.
- ESRD maintained on thrice weekly HD
- Stable Heparin prescription (Heparin dose) for the previous 4 weeks
- Dialyzed using bolus heparin anticoagulation with dose >/= 2000 units per treatment
- Hgb >/= 9.5 prior to study start
- eKt/V >/= 1.0 (or spKt/V >/= 1.2) in the monthly lab work prior to study start
Who cannot join
- Any laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
- Patient is maintained on Coumadin therapy or LMW heparin
- Known history of HIT, coagulopathy or any other bleeding and/or thrombotic disorders
- Patients dialyzed with < 2000 units of Heparin per treatment
- Dialyzed without heparin
- Known pregnancy
Show all 9Show fewer
- Dialyzed with reuse of hemodialyzers
- Documented clotted dialyzer or dialysis lines in last 30 days (1 month) requiring changing dialyzer, bloodlines or terminating treatment
- Randomized in a clinical trial involving anticoagulation in the last 30 days
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
DaVita Medical Center Houston
Houston, Texas, 77004
Avantus Renal Therapy-Saint Raphael Dialysis Center
New Haven, Connecticut, 06511
Irving Place Dialysis Center
New York, New York, 10003
Upper Manhattan Dialysis Clinic
New York, New York, 10025
Yorkville Dialysis Center
New York, New York, 10028
DaVita Rivercenter Dialysis Clinic
San Antonio, Texas, 78212
DaVita Downtown Dialysis Clinic
San Antonio, Texas, 78215
DaVita Northwest Medical Center
San Antonio, Texas, 78229
About this study
Official title: Citrasate® Effect On Heparin N Requirements During Hemodialysis Treatment: A Phase IV,Study to Investigate the Effects of Citrasate on Heparin N Requirements During Hemodialysis Treatment in Subjects Maintained on Thrice Weekly Hemodialysis
The purpose of this study is to determine whether the use of Citrasate®, citric acid dialysate enables the reduction of the heparin N (anticoagulant) dose in patients undergoing hemodialysis.
Read the detailed description
During hemodialysis, waste products are removed from the blood by diffusion across the dialyzer membrane into an electrolyte solution known as dialysate. Dialysate is produced from acid concentrate, bicarbonate solution and water using a three stream proportioning system that mixes the acid concentrate, bicarbonate and water to produce the final dialysate. Patients are typically anticoagulated with heparin during dialysis to prevent blood from clotting in the extracorpoeial circuit. Heparin use is associated with significant risks including the possibility of bleeding, heparin induced thrombocytopenia (HIT) and contamination. For these reasons, the possibility of reducing heparin dose while maintaining HD adequacy is clinically attractive. Citrasate® is an FDA approved acid concentrate that contains citric acid (citrate) rather than acetic acid (acetate) which is traditionally used in acid concentrate. Citrate in higher concentrations is also a known anticoagulant. We are therefore conducting this study to determine whether the use of Citrasate, citric acid dialysate enables the reduction of the heparin requirements in patients undergoing hemodialysis.
- Conditions
- Renal Dialysis
- Being tested
- Heparin N reduction
- Keywords
- End Stage Renal Disease, Renal Dialysis, Hemodialysis therapy, Heparin, Citrasate, Anticoagulant
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin N reductionDrug
Also called Citrasate®, Heparin N
Dialysis with Citrasate, acid concentrate plus 100% of patient's standard heparin N dose; Dialysis with Citrasate acid concentrate plus 80% of patient's standard heparin N dose; Dialysis with Citrasate acid concentrate plus 66.7% of patient's standard heparin N dose.
| Study group | Role | What they receive |
|---|---|---|
| Citrasate and heparin reduction | Sequential hemodialysis treatment study in which all enrollees move through four (4) separate treatment phases. Results from the separate phases will be compared to standard bicarbonate dialysis with standard does of heparin. Receives: Drug: Heparin N reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of dialyzer conductivity clearance (KECN) when dialyzed with Citrasate, acid concentrate and 80% of baseline Heparin dose compared to dialysis using standard bicarbonate dialysate and standard dose heparin N (baseline).
Measured: Baseline and 6 months
Secondary outcomes (2)
Non-inferiority of conductivity clearance when dialyzed with Citrasate and 66.7% baseline Heparin dose as compared to baseline.
Measured: Baseline and 6 months
Dialyzer or system clotting with Citrasate plus reduced Heparin compared to baseline.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Randolph Quinn
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Randolph Quinn, Fresenius Medical Care North America
- Investigators
- Jeffrey J Sands, MD MMM, Study director, Fresenius Medical Care North America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092455
- Sponsor's protocol ID
- 208-09
- Status last verified
- Aug 2011
- First submitted
- 11 Mar 2010
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citrasate® Effect On Heparin N Requirements During Hemodialysis Treatment: A Phase IV,Study to Investigate the Effects of Citrasate on Heparin N Requirements During Hemodialysis Treatment in Subjects Maintained on Thrice Weekly Hemodialysis
- ClinicalTrials.gov ID
- NCT01092455
- Acronym / sponsor ID
- 208-09
- Conditions
- Renal Dialysis
- Keywords
- End Stage Renal Disease, Renal Dialysis, Hemodialysis therapy, Heparin, Citrasate, Anticoagulant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Randolph QuinnIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Mar 2010 (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 determine whether the use of Citrasate®, citric acid dialysate enables the reduction of the heparin N (anticoagulant) dose in patients undergoing hemodialysis.
Detailed description
During hemodialysis, waste products are removed from the blood by diffusion across the dialyzer membrane into an electrolyte solution known as dialysate. Dialysate is produced from acid concentrate, bicarbonate solution and water using a three stream proportioning system that mixes the acid concentrate, bicarbonate and water to produce the final dialysate. Patients are typically anticoagulated with heparin during dialysis to prevent blood from clotting in the extracorpoeial circuit. Heparin use is associated with significant risks including the possibility of bleeding, heparin induced thrombocytopenia (HIT) and contamination. For these reasons, the possibility of reducing heparin dose while maintaining HD adequacy is clinically attractive. Citrasate® is an FDA approved acid concentrate that contains citric acid (citrate) rather than acetic acid (acetate) which is traditionally used in acid concentrate. Citrate in higher concentrations is also a known anticoagulant. We are therefore conducting this study to determine whether the use of Citrasate, citric acid dialysate enables the reduction of the heparin requirements in patients undergoing hemodialysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Citrasate and heparin reduction | – | Drug: Heparin N reductionSequential hemodialysis treatment study in which all enrollees move through four (4) separate treatment phases. Results from the separate phases will be compared to standard bicarbonate dialysis with standard does of heparin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the hemodialysis population in the participating facilities (study sites).
Key inclusion criteria (6 listed)
- Subject is capable of giving informed consent, or has an acceptable surrogate capable of giving consent on the subject's behalf.
- ESRD maintained on thrice weekly HD
- Stable Heparin prescription (Heparin dose) for the previous 4 weeks
- Dialyzed using bolus heparin anticoagulation with dose >/= 2000 units per treatment
- Hgb >/= 9.5 prior to study start
Key exclusion criteria (9 listed)
- Any laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
- Patient is maintained on Coumadin therapy or LMW heparin
- Known history of HIT, coagulopathy or any other bleeding and/or thrombotic disorders
- Patients dialyzed with < 2000 units of Heparin per treatment
- Dialyzed without heparin
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 |
|---|---|---|
| Heparin N reductionAlso: Citrasate®, Heparin NDialysis with Citrasate, acid concentrate plus 100% of patient's standard heparin N dose; Dialysis with Citrasate acid concentrate plus 80% of patient's standard heparin N dose; Dialysis with Citrasate acid concentrate plus 66.7% of patient's standard heparin N dose. | Drug | Citrasate and heparin reduction |
Primary outcome
Non-inferiority of dialyzer conductivity clearance (KECN) when dialyzed with Citrasate, acid concentrate and 80% of baseline Heparin dose compared to dialysis using standard bicarbonate dialysate and standard dose heparin N (baseline).
Time frame: Baseline and 6 months
2 secondary outcomes
Non-inferiority of conductivity clearance when dialyzed with Citrasate and 66.7% baseline Heparin dose as compared to baseline.
Time frame: Baseline and 6 months
Dialyzer or system clotting with Citrasate plus reduced Heparin compared to baseline.
Time frame: baseline and 6 months
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 2 Sep 2011.
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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.
Jeffrey J Sands, MD MMM study director
Fresenius Medical Care North America
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Dialysis, run by Randolph Quinn at 8 sites in United States.
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 6 inclusion and 9 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 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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.
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?
Non-inferiority of dialyzer conductivity clearance (KECN) when dialyzed with Citrasate, acid concentrate and 80% of baseline Heparin dose compared to dialysis using standard bicarbonate dialysate and standard dose heparin N (baseline). (time frame: Baseline and 6 months). 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 2 Sep 2011.