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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days after the intervention

Awards & highlights

SMART Trial 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.Check my eligibility

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.See study design

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.

SMART Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

SMART Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction of hemoglobin cycling in dialysis patients

Time hemoglobin levels are maintained within acceptable range

Secondary outcome measures

Reduction in quantity of drug administered to patients

SMART 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

2019

Completed Phase 4

~15850

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Intermountain Health Care, Inc.Lead Sponsor

137 Previous Clinical Trials

1,963,030 Total Patients Enrolled

Chemiti Gopal, MDPrincipal InvestigatorIntermountain Health Care, Inc.

Media Library

Algorithm model-based Aranesp doses (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05936021 — N/A

Dialysis Research Study Groups: Standard of care, Model-based Aranesp doses

Dialysis Clinical Trial 2023: Algorithm model-based Aranesp doses Highlights & Side Effects. Trial Name: NCT05936021 — N/A

Algorithm model-based Aranesp doses (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05936021 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research venture currently taking in participants?

"According to the clinicaltrials.gov website, this specific trial is no longer searching for participants. Initially posted on July 1st 2023 and last updated June 27th 2023, it has already filled its quota of patients; however there are 839 other trials currently recruiting."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Validation Study for Optimization of Anemia MAnagement in Hemodialysis Patients With End Stage Kidney Disease Using the Dialysis Anemia TReatmenT Model

2023. "Clinical Validation Study for Optimization of Anemia MAnagement in Hemodialysis Patients With End Stage Kidney Disease Using the Dialysis Anemia TReatmenT Model". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05936021.

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