NCT Number: NCT01613404
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Halifax, Nova Scotia, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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.
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.
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.
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.
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).
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.
Time frame: Up to 12 months
The number of patients achieving 80% of normal phosphate (PO4) in intervention group versus the 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.
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.
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.
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.
Time frame: Up to 12 months
Evaluation of time to AVF/AVG referral in the intervention group versus the control group.
Time frame: Up to 12 months
Evaluation of time to AVF/AVG surgery referral in the intervention group versus the control group.
Time frame: Up to 12 months
Evaluation of time to AVF or AVG utilization in the intervention group versus the 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.
Time frame: Up to 12 months
Janssen Inc.
Industry
A Prospective, Observational, Randomized Comparative Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis
Acronym: PROSTARRT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07344922
Anemia, Calcinosis
Al Mansurah, Dakahlia Governorate, Egypt
View Trial DetailsNCT02964936
Anemia, Chronic Disease
Numakunai, Iwate, Japan
View Trial DetailsNCT02988973
Anemia, Chronic Disease
Kasugai, Aichi-ken, Japan
View Trial DetailsNCT01906489
Anemia, Chronic Disease
Glendale, Arizona, United States
View Trial Details