Anemia Management Algorithm for Chronic Kidney Failure

(SMART Trial)

Recruiting at 1 trial location

Overseen By Mark Durst

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Intermountain Health Care, Inc.

Must be taking: Darbepoetin alfa

Must not be taking: Procrit

Disqualifiers: Active cancer, GI bleed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a human subject research study conducted in patients undergoing dialysis treatment with darbepoetin alfa at Intermountain Utah Dialysis and Intermountain Medical Center Dialysis Services. The purpose is to test a dose recommendation algorithm that may reduce hemoglobin variability and drug cost.

Research Team

Chemiti Gopal, MD

Principal Investigator

Intermountain Health Care, Inc.

Eligibility Criteria

This trial is for adults with End Stage Kidney Disease on hemodialysis who have stable anemia management, without hospitalization for the last 150 days. It's not for those with high inflammation, active cancer, severe parathyroid issues, different anemia treatments than Aranesp, recent GI bleeding or relevant hospitalizations.

Inclusion Criteria

I have 150 days of hemoglobin data and Aranesp doses without being hospitalized for anemia.

I am 18 or older with severe kidney disease and receive dialysis at a center.

Exclusion Criteria

I have been hospitalized for kidney failure in the last 150 days or during the study.

Your blood ferritin levels are higher than 1000 ng/mL, indicating inflammation.

Your parathyroid hormone (PTH) level is higher than 1,000 pg/mL.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive model-based Aranesp doses calculated by the algorithm instead of standard care procedures

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on hemoglobin levels and drug administration

4 weeks

Treatment Details

Interventions

• Algorithm model-based Aranesp doses
• Standard of care

Trial Overview The study tests a new algorithm to determine doses of Aranesp (a drug used to treat anemia in dialysis patients) against the standard care. The goal is to see if this method can make hemoglobin levels more stable and reduce treatment costs.

Participant Groups

Group I: Standard of care Experimental Treatment 1 Intervention

All patients placed on dialysis receive standard of care

Group II: Model-based Aranesp doses Experimental Treatment 1 Intervention

On entering the study cohort, patients will begin receiving doses calculated by the algorithm instead of by the standard of care procedures. Model-based Aranesp doses will be computed at the same time that doses based on the dialysis anemia protocol are determined. The model-based doses will be administered instead of the protocol-based doses and in the same way and at the same time as the protocol-based doses would have been.

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+