Anemia Management Algorithm for Chronic Kidney Failure

(SMART Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing anemia (a condition characterized by insufficient healthy red blood cells) in individuals with chronic kidney failure on dialysis. Researchers aim to determine if an algorithm for dosing Aranesp (a medication for anemia) is more effective than the standard dosing method. The goal is to reduce fluctuations in hemoglobin levels and lower drug costs. The study seeks participants who have been on dialysis, have been receiving Aranesp, and have not been hospitalized for anemia-related issues in the past 150 days. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance anemia management for many patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that patients receiving Procrit instead of Aranesp are excluded, which might imply a focus on specific anemia treatments.

What prior data suggests that this algorithm is safe for anemia management in chronic kidney failure patients?

Research shows that using Aranesp (darbepoetin alfa) doses, determined by a specific method, is generally safe for people with chronic kidney disease. Previous studies found that patients handled the doses well, and any side effects were manageable. Another study found no significant difference in death rates between patients using darbepoetin alfa and those using a similar drug, suggesting that the treatment does not increase the risk of death. While Aranesp is already part of standard care, this trial tests a new way to decide on doses. Overall, the evidence suggests that this dosing method is safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Anemia Management Algorithm for Chronic Kidney Failure trial because it introduces a novel way to determine Aranesp doses, potentially optimizing anemia management for patients on dialysis. Unlike traditional methods where doses are determined based on standard protocols, this trial uses an algorithm to calculate personalized doses of Aranesp. This approach aims to offer a more tailored treatment, which could lead to better patient outcomes by ensuring more precise management of anemia. The hope is that this algorithmic method will improve the effectiveness and efficiency of anemia treatment compared to the current standard of care.

What evidence suggests that this algorithm is effective for managing anemia in chronic kidney failure?

Research has shown that a computer program for adjusting doses of darbepoetin alfa (Aranesp) can help patients achieve their target hemoglobin and iron levels more effectively. In this trial, participants in the model-based Aranesp doses arm will receive doses calculated by the algorithm rather than standard procedures. One study found that when a pharmacist used this program to manage doses, patients experienced better outcomes. This suggests that this method could improve treatment for people with chronic kidney failure on dialysis. Additionally, this approach has demonstrated manageable side effects for patients. Overall, these findings support the potential effectiveness of a computer-based dosing program in managing anemia in this context. ^{1 2 3 5 6}

Who Is on the Research Team?

Chemiti Gopal, MD

Principal Investigator

Intermountain Health Care, Inc.

Are You a Good Fit for This Trial?

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.

My cancer is currently active.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7383089/

A pharmacist‐managed dosing algorithm for darbepoetin ... A pharmacist‐managed dosing algorithm for DA and iron sucrose increased the attainment of target levels for hemoglobin and iron status.

2. withpower.com withpower.com/trial/anemia-management-algorithm-for-chronic-kidney-failure-af0fd

Anemia Management Algorithm for Chronic Kidney Failure ... ... Algorithm model-based Aranesp doses and Standard of care will have tolerable side effects & efficacy for patients with Dialysis. Learn more about the study.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05936021

Clinical Validation Study for Optimization of Anemia ... 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 ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa0907845

A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic ... In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4485593/

Mortality Risk of Darbepoetin Alfa versus Epoetin Alfa in ... We sought to identify from the literature all randomized trials comparing EPO versus DPO for the treatment of anemia in adult patients with chronic kidney ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0085253823003794

Novel anemia therapies in chronic kidney disease Anemia is common in patients with chronic kidney disease and is associated with a high burden of morbidity and adverse clinical outcomes. In 2012, Kidney ...