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Procedure

Anemia Management Algorithm for Chronic Kidney Failure (SMART Trial)

N/A

Waitlist Available

Led By Chemiti Gopal, MD

Research Sponsored by Intermountain Health Care, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females (≥ 18 years of age) with End Stage Kidney Disease undergoing in-center hemodialysis

Be older than 18 years old

Must not have

Patients with active cancer

Patients receiving Procrit rather than Aranesp

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days after the intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an algorithm to reduce hemoglobin variability and drug cost in dialysis patients being treated with darbepoetin alfa.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include reactions at injection sites or changes in blood pressure due to altered dosing of Aranesp when following the new algorithm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is currently active.

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I am taking Procrit instead of Aranesp.

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I am currently experiencing bleeding in my digestive tract.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days after the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction of hemoglobin cycling in dialysis patients

Time hemoglobin levels are maintained within acceptable range

Secondary study objectives

Reduction in quantity of drug administered to patients

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of careExperimental Treatment1 Intervention

All patients placed on dialysis receive standard of care

Group II: Model-based Aranesp dosesExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of care

2020

Completed Phase 4

~17710

0 / 4Eligibility criteria met