What side effects are associated with this type of intervention?

Common treatments for kidney failure, particularly those involving kidney transplantation and immunosuppressive therapy, have several known side effects. Tacrolimus and cyclosporine, two frequently used immunosuppressants, can cause nephrotoxicity, hypertension, hyperglycemia, and increased risk of infections. Other side effects include gastrointestinal issues, tremors, and an increased risk of malignancies. Additionally, medications like mycophenolate and azathioprine can lead to bone marrow suppression, resulting in anemia, leukopenia, and thrombocytopenia. High-dose corticosteroids, often used in conjunction with these drugs, can cause weight gain, osteoporosis, and mood changes.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney failure, particularly focusing on immunosuppressive therapies to prevent organ rejection post-transplant. Key drugs include calcineurin inhibitors like tacrolimus and cyclosporine, antiproliferative agents such as mycophenolate mofetil, and mTOR inhibitors like sirolimus. Additionally, corticosteroids are commonly used in various dosing regimens to manage inflammation and immune response. The Donor Plan Donor Choice tool, which facilitates shared decision-making, aligns with these treatments by helping patients and providers make informed choices about donor types and transplantation options.

What other types of research exist?

Promising alternatives to the Donor Plan Donor Choice tool for kidney failure patients include the use of virtual crossmatching to improve organ allocation for highly sensitized patients, machine perfusion techniques to enhance graft function, and expanded use of marginal and dual kidney transplants to increase organ availability. Additionally, integrating telehealth platforms for blood pressure management and comprehensive cardiac assessments can support better pre-transplant evaluations and post-transplant care.

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Shared Decision Making Tool for Kidney Transplant Candidates

Q: What is the mechanism of action of this treatment?

The most common treatments for kidney failure include plasmapheresis, immunosuppressive therapy, and kidney transplantation. Plasmapheresis works by removing circulating antibodies that attack the kidneys, which is crucial for conditions like anti-GBM disease. Immunosuppressive therapy, using drugs like cyclophosphamide and prednisone, suppresses the immune system to prevent further kidney damage. Kidney transplantation replaces the failed kidney with a healthy one from a donor, restoring kidney function. These treatments are vital as they address the underlying causes of kidney failure and improve patient outcomes. Shared decision-making tools like Donor Plan Donor Choice help patients understand these options and make informed decisions about their treatment.

N/A

Recruiting

Research Sponsored by Hennepin Healthcare Research Institute

Eligibility Criteria Checklist

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

Must have

18 Years of age or older

Candidate on the kidney transplant waiting list

Must not have

< 18 years of age

Patients who choose to opt out of research

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help kidney transplant candidates make better decisions by using an online tool that educates them about donor options, facilitates discussions with doctors, and gathers their preferences.

Who is the study for?

This trial is for English-speaking adults over 18 who have been on the kidney transplant waiting list for more than three months. It's not suitable for those under 18, non-English speakers, patients who opt out of research, or anyone unable to give informed consent.

What is being tested?

The study tests a tool called 'Donor Plan Donor Choice' designed to help kidney transplant candidates make decisions with their doctors about organ offers. Participants will use an online educational tool and discuss donor types with providers.

What are the potential side effects?

Since this trial involves decision-making support rather than medical treatment, there are no direct physical side effects. However, participants may experience stress or anxiety when considering different donor options.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I am on the waiting list for a kidney transplant.

Exclusion Criteria

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

Select...

I am under 18 years old.

Select...

I choose not to participate in research studies.

Select...

I am unable to understand and agree to the study's details on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Willingness to accept donor organs at risk of discard

Secondary study objectives

Decisional Conflict

Distress

Knowledge

+1 more

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

Active Control

Group I: Shared Decision Making InterventionExperimental Treatment1 Intervention

Receives the Shared Decision Making Intervention

Group II: Usual CareActive Control1 Intervention

Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for kidney failure include plasmapheresis, immunosuppressive therapy, and kidney transplantation. Plasmapheresis works by removing circulating antibodies that attack the kidneys, which is crucial for conditions like anti-GBM disease. Immunosuppressive therapy, using drugs like cyclophosphamide and prednisone, suppresses the immune system to prevent further kidney damage. Kidney transplantation replaces the failed kidney with a healthy one from a donor, restoring kidney function. These treatments are vital as they address the underlying causes of kidney failure and improve patient outcomes. Shared decision-making tools like Donor Plan Donor Choice help patients understand these options and make informed decisions about their treatment.

Deleting Death and Dialysis: Conservative Care of Cardio-Vascular Risk and Kidney Function Loss in Chronic Kidney Disease (CKD).Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy.Preventing stroke and systemic embolism in renal patients with atrial fibrillation: focus on anticoagulation.