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

NCT01092455 | Completed

• 1 other identifier: 208-09
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Renal Dialysis

Keywords

End Stage Renal Disease; Renal Dialysis; Hemodialysis therapy; Heparin; Citrasate; Anticoagulant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Heparin N reduction DRUG

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.

Also known as: Citrasate®, Heparin N

Citrasate and heparin reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Randolph Quinn: lead

Study Sites (8)

Avantus Renal Therapy-Saint Raphael Dialysis Center

New Haven, Connecticut, 06511, United States

Location

Irving Place Dialysis Center

New York, New York, 10003, United States

Location

Upper Manhattan Dialysis Clinic

New York, New York, 10025, United States

Location

Yorkville Dialysis Center

New York, New York, 10028, United States

Location

DaVita Medical Center Houston

Houston, Texas, 77004, United States

Location

DaVita Rivercenter Dialysis Clinic

San Antonio, Texas, 78212, United States

Location

DaVita Downtown Dialysis Clinic

San Antonio, Texas, 78215, United States

Location

DaVita Northwest Medical Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey J Sands, MD MMM

  Fresenius Medical Care North America

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Manager, Regulatory Affairs

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 25, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 2, 2011

Record last verified: 2011-08

Locations

US (8)