Multi-center Study to Investigate the Effects of Citrasate® on Heparin N Requirements During Hemodialysis Treatment

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.

Study Overview

• Status: Completed
• Conditions: Renal Dialysis
• Intervention / Treatment: Drug: Heparin N reduction

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Avantus Renal Therapy-Saint Raphael Dialysis Center
  • New York
    • New York, New York, United States, 10003
      • Irving Place Dialysis Center
    • New York, New York, United States, 10025
      • Upper Manhattan Dialysis Clinic
    • New York, New York, United States, 10028
      • Yorkville Dialysis Center
  • Texas
    • Houston, Texas, United States, 77004
      • DaVita Medical Center Houston
    • San Antonio, Texas, United States, 78212
      • DaVita Rivercenter Dialysis Clinic
    • San Antonio, Texas, United States, 78215
      • DaVita Downtown Dialysis Clinic
    • San Antonio,, Texas, United States, 78229
      • DaVita Northwest Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the hemodialysis population in the participating facilities (study sites).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Heparin N reduction; 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.; Other Names: Citrasate®; Heparin N

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Non-inferiority of conductivity clearance when dialyzed with Citrasate and 66.7% baseline Heparin dose as compared to baseline.	Baseline and 6 months
Dialyzer or system clotting with Citrasate plus reduced Heparin compared to baseline.	baseline and 6 months

Collaborators and Investigators

• Sponsor: Randolph Quinn
• Investigators: Study Director: Jeffrey J Sands, MD MMM, Fresenius Medical Care North America

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: March 11, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (Estimate): March 25, 2010

Study Record Updates

• Last Update Posted (Estimate): September 2, 2011
• Last Update Submitted That Met QC Criteria: August 31, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Heparin; Anticoagulant; Renal Dialysis; Hemodialysis therapy; Citrasate
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: 208-09