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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Janssen Inc.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT01613404
First received: June 5, 2012
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Chronic Kidney Disease
Other: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational, Randomized Comparative Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis

Resource links provided by NLM:


Further study details as provided by Janssen Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Number of patients in intervention group achieving urea reduction ratio (URR) >70% (based on most recent value) as compared to control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The number of patients achieving 80% of urea reduction ratio (URR) >70% (based on most recent value) in intervention group versus the control group.

  • Number of patients achieving functioning arterio-venous fistula/arterio-venous graft (AVF/AVG) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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).

  • Number of patients in intervention group achieving albumin >lower limit of normal (LLN) as compared to control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The number of patients achieving 80% of albumin >LLN (based on that center's serum albumin assay) in intervention group versus the control group.

  • Number of patients in intervention group achieving normal phosphate (PO4) as compared to control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The number of patients achieving 80% of normal phosphate (PO4) in intervention group versus the control group.

  • Comparison of Quality of Life scores in the intervention group and control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Comparison of dialysis knowledge test scores in the intervention group and control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Dialysis Knowledge test scores at baseline, 3, 6 and 12 months in the intervention group versus the control group.

  • Comparison of resource utilization in the intervention group and control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Comparison of erythropoiesis stimulating agent (ESA) utilization patterns in the intervention group and control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Comparison of time to AVF/AVG referral in the intervention group and control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Evaluation of time to AVF/AVG referral in the intervention group versus the control group.

  • Comparison of time to AVF/AVG surgery in the intervention group and control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Evaluation of time to AVF/AVG surgery referral in the intervention group versus the control group.

  • Comparison of time to AVF or AVG utilization in the intervention group and control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Evaluation of time to AVF or AVG utilization in the intervention group versus the control group.

  • Comparison of time to removal of central venous catheter (CVC) in the intervention group and control group [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Evaluation of time to removal of central venous catheter (CVC) in the intervention group versus the control group.

  • Number of participants with adverse events as measure of safety [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 900
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with nurse case manager
Patients will receive a dedicated nurse case manager (intervention group) in this group.
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.
Patients with no nurse case manager
Patients will not receive nurse case manager (control group) in this group.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic kidney disease

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613404

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
Canada, Alberta
Recruiting
Calgary, Alberta, Canada
Canada, Manitoba
Not yet recruiting
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Active, not recruiting
Halifax, Nova Scotia, Canada
Active, not recruiting
Sydney, Nova Scotia, Canada
Canada, Ontario
Active, not recruiting
Kingston, Ontario, Canada
Active, not recruiting
London, Ontario, Canada
Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Withdrawn
Laval, Quebec, Canada
Active, not recruiting
Montreal, Quebec, Canada
Recruiting
Montreal, Quebec, Canada
Completed
Montreal, Quebec, Canada
Completed
Point Claire, Quebec, Canada
Canada, Saskatchewan
Active, not recruiting
Regina, Saskatchewan, Canada
Canada
Not yet recruiting
Edmonton N/A, Canada
Active, not recruiting
Greenfield Park, Canada
Active, not recruiting
Montreal, Canada
Active, not recruiting
Saskatoon, Canada
Active, not recruiting
St. John, Canada
Active, not recruiting
Toronto, Canada
Completed
Verdun, Canada
Sponsors and Collaborators
Janssen Inc.
Investigators
Study Director: Janssen Inc. Clinical Trial Janssen Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Inc.
ClinicalTrials.gov Identifier: NCT01613404     History of Changes
Other Study ID Numbers: CR016009, EPO-ANE-4080
Study First Received: June 5, 2012
Last Updated: September 2, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Janssen Inc.:
Chronic kidney disease
Hemodialysis
Eprex
Aranesp
ESA
Anemia

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 16, 2014