An Observational Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis

Chronic Kidney Disease Clinical Trial

— PROSTARRT  

Official title:

A Prospective, Observational, Randomized Comparative Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613404
• Other study ID #: CR016009
• Secondary ID: EPO-ANE-4080
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2012
• Last updated: January 20, 2016
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Janssen Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• No intervention
Patients will be treated with approved erythropoiesis stimulating agent (Eprex or Aranesp) will be administered according to actual clinical practice according to guidance in the current approved product monographs. All patients will receive treatments that are prescribed by their physician according to actual clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of 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).	Up to 12 months	No
Secondary	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	The number of patients achieving 80% of dry weight (the amount of body mass [weight] without extra fluid [water])with normal blood pressure and no signs of volume overload in intervention group versus the control group.	Up to 12 months	No
Secondary	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	The number of patients achieving 80% of intra-dialytic weight gain (IDWG) <3Kg (based on the average over last week) in intervention group versus the control group.	Up to 12 months	No
Secondary	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	The number of patients achieving 80% of hemoglobin (Hb) targeted according to guidance in the current and approved product monograph (value based on the most recent Hb result) in intervention group versus the control group.	Up to 12 months	No
Secondary	Number of patients in intervention group achieving urea reduction ratio (URR) >70% (based on most recent value) as compared to control group	The number of patients achieving 80% of urea reduction ratio (URR) >70% (based on most recent value) in intervention group versus the control group.	Up to 12 months	No
Secondary	Number of patients achieving functioning arterio-venous fistula/arterio-venous graft (AVF/AVG)	The number of patients achieving 80% of functioning arterio-venous fistula/arterio-venous graft (AVF/AVG) in intervention group (case managed) versus the control group (non-case managed).	Up to 12 months	No
Secondary	Number of patients in intervention group achieving albumin >lower limit of normal (LLN) as compared to control group	The number of patients achieving 80% of albumin >LLN (based on that center's serum albumin assay) in intervention group versus the control group.	Up to 12 months	No
Secondary	Number of patients in intervention group achieving normal phosphate (PO4) as compared to control group	The number of patients achieving 80% of normal phosphate (PO4) in intervention group versus the control group.	Up to 12 months	No
Secondary	Comparison of Quality of Life scores in the intervention group and control group	Evaluation of Quality of Life scores at baseline, 3, 6, 9 and 12 months as determined by the kidney disease quality of life (questionnaire) in the intervention group versus the control group.	Up to 12 months	No
Secondary	Comparison of dialysis knowledge test scores in the intervention group and control group	Dialysis Knowledge test scores at baseline, 3, 6 and 12 months in the intervention group versus the control group.	Up to 12 months	No
Secondary	Comparison of resource utilization in the intervention group and control group	Resource utilization will be evaluated on the basis of number and duration of medical care encounters, including surgeries, and other procedures, duration of hospitalization, medications received in hospital which are not protocol driven, outpatient medical encounters and treatments, cost of red blood cells transfusions, cost of hospitalization, and cost of renal replacement therapy.	Up to 12 months	No
Secondary	Comparison of erythropoiesis stimulating agent (ESA) utilization patterns in the intervention group and control group	ESA utilization patterns of such as dose adjustments, frequency of administration, length of titration phase, overall dose, and patterns of Hb control and variability, the increase of Hb from baseline, the maintenance of Hb concentration, the proportion of patients who exceed the Hb ceiling, the maximum Hb value, the rate of rise of Hb, the maximum rate of rise of Hb, and overall safety when Hb is targeted to the standard of care utilized at the participating centre in the intervention group versus the control group.	Up to 12 months	No
Secondary	Comparison of time to AVF/AVG referral in the intervention group and control group	Evaluation of time to AVF/AVG referral in the intervention group versus the control group.	Up to 12 months	No
Secondary	Comparison of time to AVF/AVG surgery in the intervention group and control group	Evaluation of time to AVF/AVG surgery referral in the intervention group versus the control group.	Up to 12 months	No
Secondary	Comparison of time to AVF or AVG utilization in the intervention group and control group	Evaluation of time to AVF or AVG utilization in the intervention group versus the control group.	Up to 12 months	No
Secondary	Comparison of time to removal of central venous catheter (CVC) in the intervention group and control group	Evaluation of time to removal of central venous catheter (CVC) in the intervention group versus the control group.	Up to 12 months	No
Secondary	Number of participants with adverse events as measure of safety		Up to 12 months	Yes