CAPABLE Program for Kidney Failure

Overseen By Samantha Curriero, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Severe cognitive impairment, cancer treatment, others

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

Compensation: Varies

Number of Visits: 12

43 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people on the kidney transplant waitlist by addressing issues that prevent them from being listed as active candidates. It tests a program called CAPABLE Transplant, designed to improve health and readiness for surgery, focusing on those who are pre-frail or frail. Researchers will sort participants into different groups to evaluate the program's effectiveness. The trial seeks individuals on the deceased donor waitlist who are currently inactive or have low income and have faced issues like heart disease, frailty, or lack of support. As an unphased trial, this study offers participants a unique opportunity to potentially improve their health and readiness for a transplant.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CAPABLE Transplant intervention is safe?

Research has shown that kidney transplants are usually very successful. For patients receiving a kidney from a living donor, 97.3% survive after one year, and 95.9% survive after three years. This indicates that most people handle the transplant process well. Additionally, 92% of studies indicate that kidney transplants help people live longer compared to staying on dialysis. These results are encouraging for those considering a kidney transplant, suggesting that the procedure is generally safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CAPABLE Transplant program because it represents a new approach to kidney failure treatment. Unlike traditional options like dialysis or standard kidney transplants, CAPABLE focuses on optimizing the transplant process itself to potentially improve outcomes for patients on the waitlist. This method seeks to streamline and enhance the way transplants are administered, which could lead to better success rates and faster recoveries. The program ensures that all participants gain access to the intervention, highlighting its inclusive and patient-centered design.

What evidence suggests that the CAPABLE Transplant intervention could be effective for kidney transplant candidates?

Research has shown that helping patients overcome obstacles to kidney transplant eligibility can lead to better outcomes. Patients who improve their physical strength and health before surgery often recover faster and live longer. Studies have found that preparing for a transplant in advance can reduce the risk of death and improve kidney function post-surgery. This preparation strengthens patients and better equips them for surgery, increasing the likelihood of a successful transplant. While specific data for the CAPABLE Transplant intervention, which participants in this trial may receive, is limited, similar methods have improved transplant success. ^{6 7 8 9 10}

Who Is on the Research Team?

Melissa Hladek, PhD

Principal Investigator

Johns Hopkins School of Nursing

Are You a Good Fit for This Trial?

This trial is for people over 50 on the deceased donor waitlist for a kidney transplant, living at home, who are currently inactive or were recently due to health or social issues. It's not for those with severe cognitive problems, expected long-term inactivity, frequent hospitalizations, or current home therapy.

Inclusion Criteria

Deceased Donor Waitlist

I am 50 years old or older.

Community dwelling

Exclusion Criteria

Living Donor Waitlist

I am currently receiving home nursing or therapy.

I have been hospitalized more than 4 times in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open Label Pilot

Testing the CAPABLE Transplant intervention with 3 individuals on the waitlist

4 months

6 home visits by OT, 4 home visits by RN

Randomized Control Pilot - Intervention Arm

15 participants receive the CAPABLE Transplant intervention

4 months

6 home visits by OT, 4 home visits by RN

Randomized Control Pilot - Waitlist Control Arm

15 participants serve as controls and then receive the intervention

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CAPABLE Transplant

Trial Overview

CAPABLE Transplant aims to help patients overcome barriers to being active on the kidney transplant list and prepare them physically and mentally for surgery. The study has two parts: an initial pilot test where everyone gets the intervention and a second part where participants are randomly chosen to receive it.

How Is the Trial Designed?

Group I: Randomized Control Pilot- Intervention Arm Experimental Treatment 1 Intervention

After the open label pilot, 20 participants will be randomized to the CAPABLE Transplant intervention. They will be assessed at baseline, after the 4 month intervention, and after the waitlist control arm.

Group II: Open Label Pilot Experimental Treatment 1 Intervention

The Open Label Pilot will include testing the CAPABLE Transplant intervention with 3 individuals on the waitlist.

Group III: Randomized Control Pilot- Waitlist Control Arm Active Control 1 Intervention

The waitlist control group, 20 participants, will receive the intervention after they have served as controls to the immediate treatment group, ensuring all participants have access to the intervention.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Kidney transplantation (KT) can be successfully performed in physically handicapped patients with mental retardation, as demonstrated by a study of 25 patients, all of whom had functioning grafts after a mean follow-up of 41.1 months.

Despite some complications, such as acute rejection episodes that were effectively treated, the overall satisfaction of caregivers and improved quality of life for recipients suggest that KT is a viable option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kidney transplantation in pediatric recipients with mental retardation: clinical results of a multicenter experience in Japan. Ohta, T., Motoyama, O., Takahashi, K., et al.[2011]

In a study of 15 dual kidney transplants performed since 2001, 14 recipients remained alive with functioning grafts after a mean follow-up of 26.3 months, indicating that dual kidney transplants can be a viable option for patients with borderline donor kidneys.

The positioning of the transplanted kidneys in separate iliac fossae reduced the rate of surgical complications, suggesting that careful surgical technique is important for the success of dual kidney transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dual kidney transplant: the E. Herriot Hospital Lyon experience]. Rognant, N., Codas Duarte, R., De la Torre Abril, L., et al.[2008]

Kidney transplantation significantly enhances both survival and quality of life for patients with end-stage renal disease compared to dialysis.

Preemptive kidney transplantation, performed before starting dialysis, is associated with better patient and graft survival rates, highlighting the need for early referral to nephrologists and transplant centers for patients with chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preemptive kidney transplantation in patients with diabetes mellitus. Dinavahi, R., Akalin, E.[2007]

Recent advancements in technology and immunology have led to various effective treatments for end-stage renal disease (ESRD), but none provide a permanent solution except for identical twin kidney transplants.

An integrated approach combining dialysis and renal transplantation, tailored to individual patient needs, has been shown to optimize long-term health and quality of life, with over 90% graft survival expected in non-sensitized first-graft recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialysis or transplant: an integrated approach to end-stage kidney disease management. Keown, PA., Stiller, CR.[2005]

In a study of 152 transplant recipients, a scoring system based on immune function parameters revealed that 85% had B-cell lymphopenia, indicating significant immune system abnormalities that could affect infection risk.

Patients with lower immune competence scores experienced a significantly higher rate of infections, suggesting that this scoring system could help predict complications related to immunosuppression in transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory assessment of immune function in renal transplant patients. Hutchinson, P., Chadban, SJ., Atkins, RC., et al.[2019]

In a study of 4,110 kidney transplant recipients, 38.9% of those hospitalized experienced adverse safety events, highlighting the significant risk of complications in this population.

Factors such as lower estimated glomerular filtration rate (GFR), history of cardiovascular disease, and diabetes were associated with a higher incidence of these safety events, indicating the need for careful monitoring and management of medications in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety events in kidney transplant recipients: results from the folic Acid for vascular outcome reduction in transplant trial. Weir, MR., Gravens-Muller, L., Costa, N., et al.[2018]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

Patients with chronic kidney disease (CKD) are particularly vulnerable to adverse drug events during hospitalization, which can lead to significant harm.

The study emphasizes the need for new strategies to minimize medical errors and improve safety for CKD patients in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. Fink, JC., Chertow, GM.[2022]

In a study of 100 consecutive live donor kidney transplants over 25 months, the patient survival rate was an impressive 98%, and the graft survival rate was 90%, indicating high efficacy of this treatment.

The use of live donor transplants not only resulted in excellent renal function for most patients but also suggested significant cost savings in healthcare, potentially saving $3.6 million every two years by preventing the need for dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the results of live donor kidney transplantation be improved? Glass, NR., Miller, DT., Sollinger, HW., et al.[2004]

In regions with high competition among transplant centers, a greater percentage of end-stage renal disease (ESRD) patients are listed for kidney transplants, with 19.73% listed in competitive areas compared to only 13.75% in highly concentrated areas.

The study indicates that competition among transplant centers can lead to increased access for ESRD patients to transplantation, highlighting a potential disparity in patient access based on regional competition levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Competitive Market Analysis of Transplant Centers and Discrepancy of Wait-Listing of Recipients for Kidney Transplantation. Cho, PS., Saidi, RF., Cutie, CJ., et al.[2020]

Chronic kidney disease (CKD) that does not require dialysis significantly increases the risk of adverse safety events, which can lead to poor patient outcomes, highlighting the need for better safety measures in CKD care.

Medication errors are prevalent in CKD patients and contribute to safety lapses, indicating that a standardized set of disease-specific safety indicators is essential for improving patient safety and outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. Fink, JC., Joy, MS., St Peter, WL., et al.[2019]

Chronic kidney disease (CKD) is often underrecognized in healthcare, making it a high-risk condition for safety events that can worsen kidney function and lead to end-stage renal disease.

Improving recognition of CKD and implementing disease-specific safety indicators could help reduce adverse safety events and slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. Fink, JC., Brown, J., Hsu, VD., et al.[2023]

In the first year of Al-Basheer Hospital's kidney transplant program, 20 transplants were performed with no donor mortality and a low complication rate, indicating a safe procedure for living and deceased donors.

Recipient outcomes were promising, with no mortality among patients, although 6 experienced complications, including acute cellular rejection and slow graft function, suggesting that while the program is effective, careful monitoring and management of complications are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Results of a Newly Established Organ Transplantation Program in a Teaching Hospital. Momani, H., Algeizawi, S., Shamoun, B., et al.[2017]

The introduction of new immunosuppressive drugs has significantly improved kidney transplantation outcomes, with a 1-year graft survival rate of about 85% for cadaver kidney transplants.

The article reviews existing immunosuppressive agents and discusses ongoing clinical trials for new drugs, highlighting advancements in induction and maintenance therapy as well as treatment for acute rejection episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of immunosuppressive agents in renal transplantation. First, MR.[2021]

In a study of 100 consecutive kidney transplant patients, the overall patient survival rate was an impressive 98%, and the graft survival rate was 96%, indicating significant improvements in transplantation outcomes.

The analysis included both living and cadaveric donors, with the majority of donor deaths due to cerebrovascular disease, highlighting the importance of donor health in transplantation success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Outcomes of 100 Consecutive Kidney Transplantations in a 3-Year Period: A Single-Center Experience. Alfaro Sanchez, CI., Molina Higueras, MJ., Moiron Fernandez-Felechosa, JP., et al.[2018]

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