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

Janssen (J&J Innovative Medicine)

Status

Completed

Conditions

Chronic Kidney Disease

Treatments

Other: No intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT01613404

CR016009

EPO-ANE-4080 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

248 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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