Chronic Kidney DiseasePROSTARRTNCT01613404
An Observational Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis
An observational study of Chronic Kidney Disease, run by Janssen Inc. at 14 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 248 participants
- Where
- 14 sitesCanada
- Study dates
- Feb 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic kidney disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
Study site
Greenfield Park
Study site
Halifax, Nova Scotia
Study site
Kingston, Ontario
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Montreal
Study site
Point Claire, Quebec
Study site
Regina, Saskatchewan
Study site
Saskatoon
Study site
St. John's
Study site
Sydney, Nova Scotia
Study site
Toronto, Ontario
Study site
Toronto
Study site
Verdun
About this study
Official title: 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).
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- No intervention
- Keywords
- Chronic kidney disease, Hemodialysis, Eprex, Aranesp, ESA, Anemia
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with nurse case manager | Patients will receive a dedicated nurse case manager (intervention group) in this group. Receives: Other: No intervention | |
| Patients with no nurse case manager | Patients will not receive nurse case manager (control group) in this group. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
The number of patients achieving 80% of urea reduction ratio (URR) >70% (based on most recent value) in intervention group versus the control group.
Measured: Up to 12 months
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).
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
Number of participants with adverse events as measure of safety
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Inc. Clinical Trial, Study director, Janssen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613404
- Sponsor's protocol ID
- CR016009
- Other IDs
- EPO-ANE-4080
- Acronym
- PROSTARRT
- Status last verified
- Jan 2016
- First submitted
- 5 Jun 2012
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Randomized Comparative Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis
- ClinicalTrials.gov ID
- NCT01613404
- Acronym / sponsor ID
- PROSTARRT / CR016009
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Hemodialysis, Eprex, Aranesp, ESA, Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Janssen Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with nurse case manager | – | Other: No interventionPatients will receive a dedicated nurse case manager (intervention group) in this group. |
| Patients with no nurse case manager | – | Other: No interventionPatients will not receive nurse case manager (control group) in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionPatients 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. | Other | Patients with no nurse case manager, Patients with nurse case manager |
Primary outcome
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).
16 secondary outcomes
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
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
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
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
Number of patients achieving functioning arterio-venous fistula/arterio-venous graft (AVF/AVG)
Time frame: 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
Number of patients in intervention group achieving normal phosphate (PO4) as compared to control group
Time frame: Up to 12 months
Comparison of Quality of Life scores in the intervention group and control group
Time frame: Up to 12 months
Comparison of dialysis knowledge test scores in the intervention group and control group
Time frame: Up to 12 months
Comparison of resource utilization in the intervention group and control group
Time frame: 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
Comparison of time to AVF/AVG referral in the intervention group and control group
Time frame: Up to 12 months
Comparison of time to AVF/AVG surgery in the intervention group and control group
Time frame: 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
Comparison of time to removal of central venous catheter (CVC) in the intervention group and control group
Time frame: Up to 12 months
Number of participants with adverse events as measure of safety
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Inc. Clinical Trial study director
Janssen Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Janssen Inc. at 14 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.