- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01613404
An Observational Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis (PROSTARRT)
January 20, 2016 updated by: Janssen Inc.
A Prospective, Observational, Randomized Comparative Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis
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).
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
248
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Greenfield Park, Canada
-
Montreal, Canada
-
Saskatoon, Canada
-
St. John, Canada
-
Toronto, Canada
-
Verdun, Canada
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada
-
Sydney, Nova Scotia, Canada
-
-
Ontario
-
Kingston, Ontario, Canada
-
London, Ontario, Canada
-
Toronto, Ontario, Canada
-
-
Quebec
-
Montreal, Quebec, Canada
-
Point Claire, Quebec, Canada
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with chronic kidney disease
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with nurse case manager
Patients will receive a dedicated nurse case manager (intervention group) in this group.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Number of patients achieving functioning arterio-venous fistula/arterio-venous graft (AVF/AVG)
Time Frame: Up to 12 months
|
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
|
Number of patients in intervention group achieving albumin >lower limit of normal (LLN) as compared to control group
Time Frame: Up to 12 months
|
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
|
Number of patients in intervention group achieving normal phosphate (PO4) as compared to control group
Time Frame: Up to 12 months
|
The number of patients achieving 80% of normal phosphate (PO4) in intervention group versus the control group.
|
Up to 12 months
|
Comparison of Quality of Life scores in the intervention group and control group
Time Frame: Up to 12 months
|
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
|
Comparison of dialysis knowledge test scores in the intervention group and control group
Time Frame: Up to 12 months
|
Dialysis Knowledge test scores at baseline, 3, 6 and 12 months in the intervention group versus the control group.
|
Up to 12 months
|
Comparison of resource utilization in the intervention group and control group
Time Frame: Up to 12 months
|
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
|
Comparison of erythropoiesis stimulating agent (ESA) utilization patterns in the intervention group and control group
Time Frame: Up to 12 months
|
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
|
Comparison of time to AVF/AVG referral in the intervention group and control group
Time Frame: Up to 12 months
|
Evaluation of time to AVF/AVG referral in the intervention group versus the control group.
|
Up to 12 months
|
Comparison of time to AVF/AVG surgery in the intervention group and control group
Time Frame: Up to 12 months
|
Evaluation of time to AVF/AVG surgery referral in the intervention group versus the control group.
|
Up to 12 months
|
Comparison of time to AVF or AVG utilization in the intervention group and control group
Time Frame: Up to 12 months
|
Evaluation of time to AVF or AVG utilization in the intervention group versus the control group.
|
Up to 12 months
|
Comparison of time to removal of central venous catheter (CVC) in the intervention group and control group
Time Frame: Up to 12 months
|
Evaluation of time to removal of central venous catheter (CVC) in the intervention group versus the control group.
|
Up to 12 months
|
Number of participants with adverse events as measure of safety
Time Frame: Up to 12 months
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
June 5, 2012
First Submitted That Met QC Criteria
June 6, 2012
First Posted (Estimate)
June 7, 2012
Study Record Updates
Last Update Posted (Estimate)
January 21, 2016
Last Update Submitted That Met QC Criteria
January 20, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR016009
- EPO-ANE-4080 (Other Identifier: Janssen Inc.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Kidney Disease
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteWithdrawnFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage3 | Chronic Kidney Failure | Chronic Kidney Disease, Stage 4 (Severe)
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
Centre Hospitalier Saint Joseph Saint Luc de LyonNot yet recruitingKidney Failure, Chronic | Diet Habit | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 3B | Chronic Kidney Disease, Stage 3 (Moderate) | Chronic Kidney Disease Stage 3A (Disorder)France
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
-
A.C. AbrahamsCompletedEnd Stage Renal Disease | Chronic Kidney Disease | End Stage Kidney Disease | Chronic Kidney FailureNetherlands
-
Far Eastern Memorial HospitalActive, not recruitingMetabolic Syndrome | Chronic Disease | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease Stage 3 | Chronic Kidney Disease Stage 4 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
Clinical Trials on No intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
University of PittsburghCompletedChronic Low Back PainUnited States