An Observational Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis
PROSTARRT
A Prospective, Observational, Randomized Comparative Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis
2 other identifiers
observational
248
1 country
14
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 21, 2016
January 1, 2016
2.8 years
June 5, 2012
January 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (16)
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
Up to 12 months
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
Up to 12 months
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
Up to 12 months
Number of patients in intervention group achieving urea reduction ratio (URR) >70% (based on most recent value) as compared to control group
Up to 12 months
Number of patients achieving functioning arterio-venous fistula/arterio-venous graft (AVF/AVG)
Up to 12 months
- +11 more secondary outcomes
Study Arms (2)
Patients with nurse case manager
Patients will receive a dedicated nurse case manager (intervention group) in this group.
Patients with no nurse case manager
Patients will not receive nurse case manager (control group) in this group.
Interventions
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.
Eligibility Criteria
Patients with chronic kidney disease
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Inc.lead
Study Sites (14)
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Sydney, Nova Scotia, Canada
Unknown Facility
Kingston, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Point Claire, Quebec, Canada
Unknown Facility
Regina, Saskatchewan, Canada
Unknown Facility
Greenfield Park, Canada
Unknown Facility
Montreal, Canada
Unknown Facility
Saskatoon, Canada
Unknown Facility
St. John's, Canada
Unknown Facility
Toronto, Canada
Unknown Facility
Verdun, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Inc. Clinical Trial
Janssen Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2012
First Posted
June 7, 2012
Study Start
February 1, 2012
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
January 21, 2016
Record last verified: 2016-01