Clinical trial NCT01613404: An Observational Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis
Official title: A Prospective, Observational, Randomized Comparative Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease
Hemodialysis
Eprex
Aranesp
ESA
Anemia
Lead sponsor: Janssen Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-07
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease

Brief summary: The purpose of the study is to compare the 90 day and 12 month composite end point of death (all-cause mortality) and hospitalization in incident hemodialysis patients randomized to receive support from a dedicated case manager (intervention group) versus those not receiving support from a dedicated case manager (control group).

Detailed description: This is multicenter, prospective, observational, and randomized (the study drug is assigned by chance), 1-year study, in academic and community-based nephrology clinical practices that will examine the impact of a facility nurse case manager. In this study a group of patients guideline- based, algorithm- driven approach to hemodialysis initiation with targets (as per Canadian Society of Nephrology and/or International guidelines) will be used with facility nurse case manager and in control group same approach will be used without facility nurse case manager. Patients will be treated with any approved erythropoiesis stimulating agent for the correction of anemia, according to guidance in the current approved product monographs. All treatments will be prescribed by the physician according to actual clinical practice or standard of care for chronic kidney disease. The entire study duration for each participant will be approximately 12 months.

Eligibility criteria: Inclusion Criteria:

* Patients who initiated hemodialysis and expected to be on hemodialysis for at least 1 year
* Patients initiating hemodialysis requiring treatment (erythropoiesis stimulating agent or red blood cell transfusion) to correct the anemia of chronic kidney disease who are receiving erythropoiesis stimulating agent treatment at study entry or patients who do not require erythropoiesis stimulating agent therapy (Hb within or above target range)
* Life expectancy should be more than 12 months

Exclusion Criteria:

* Patients contraindicated to receive erythropoiesis stimulating agent therapy (including but not limited to patients who develop pure red cell aplasia following treatment with any erythropoiesis stimulating agent )
* Patients entering the study on any other agent to increase red blood cell mass (such as androgen therapy, or investigational agents, or other non-approved erythropoiesis stimulating agent)
* Patients unwilling or unable to receive erythropoiesis stimulating agent therapy to correct the anemia of chronic kidney disease
* Patients with uncontrolled hypertension
* Patients who for any reason cannot receive adequate antithrombotic treatment

Primary outcomes:
measure: Comparison of the 90 day and 12 month composite end point of death (all-cause mortality) and hospitalization in incident hemodialysis patients of intervention group and control group
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of patients in intervention group achieving 80% of dry weight with normal blood pressure and no signs of volume overload as compared to control group
timeFrame: Up to 12 months
measure: Number of patients in intervention group achieving intra-dialytic weight gain (IDWG) <3Kg (based on the average over last week) as compared to control group
timeFrame: Up to 12 months
measure: Number of patients in intervention group achieving hemoglobin (Hb) targeted according to guidance in the current and approved product monograph (value based on the most recent Hb result) as compared to control group
timeFrame: Up to 12 months
measure: Number of patients in intervention group achieving urea reduction ratio (URR) >70% (based on most recent value) as compared to control group
timeFrame: Up to 12 months
measure: Number of patients achieving functioning arterio-venous fistula/arterio-venous graft (AVF/AVG)
timeFrame: Up to 12 months
measure: Number of patients in intervention group achieving albumin >lower limit of normal (LLN) as compared to control group
timeFrame: Up to 12 months
measure: Number of patients in intervention group achieving normal phosphate (PO4) as compared to control group
timeFrame: Up to 12 months
measure: Comparison of Quality of Life scores in the intervention group and control group
timeFrame: Up to 12 months
measure: Comparison of dialysis knowledge test scores in the intervention group and control group
timeFrame: Up to 12 months
measure: Comparison of resource utilization in the intervention group and control group
timeFrame: Up to 12 months
measure: Comparison of erythropoiesis stimulating agent (ESA) utilization patterns in the intervention group and control group
timeFrame: Up to 12 months
measure: Comparison of time to AVF/AVG referral in the intervention group and control group
timeFrame: Up to 12 months
measure: Comparison of time to AVF/AVG surgery in the intervention group and control group
timeFrame: Up to 12 months
measure: Comparison of time to AVF or AVG utilization in the intervention group and control group
timeFrame: Up to 12 months
measure: Comparison of time to removal of central venous catheter (CVC) in the intervention group and control group
timeFrame: Up to 12 months
measure: Number of participants with adverse events as measure of safety
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
state: Nova Scotia
city: Sydney
country: Canada
state: Nova Scotia
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Point Claire
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Greenfield Park
country: Canada
city: Montreal
country: Canada
city: Saskatoon
country: Canada
city: St. John
country: Canada
city: Toronto
country: Canada
city: Verdun
country: Canada
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References: