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?

The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial, and 3) pilot test the feasibility and acceptability for CAPABLE Transplant in symptom and waitlist specific metrics amongst low-income active kidney transplant waitlist candidates.

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.

Is the CAPABLE Program for Kidney Failure generally safe for humans?

The research highlights that patients with chronic kidney disease (CKD) and those who have had kidney transplants are at high risk for adverse safety events, often due to medication errors and complex care needs. While this doesn't directly address the CAPABLE Program, it suggests that safety concerns are common in kidney-related treatments, emphasizing the need for careful monitoring and management. ^{1 2 3 4 5}

How is the CAPABLE Transplant treatment for kidney failure different from other treatments?

The CAPABLE Transplant treatment may involve a unique approach by integrating both dialysis and renal transplantation, aiming for optimal long-term well-being and social reintegration, which is not typically emphasized in standard treatments. ^{6 7 8 9 10}

What data supports the effectiveness of the CAPABLE Transplant treatment for kidney failure?

Research shows that kidney transplantation, especially from live donors, is highly effective for treating kidney failure, with patient survival rates as high as 98% and graft survival rates around 90% over two years. Additionally, preemptive kidney transplantation (before dialysis) improves both patient survival and quality of life. ^{11 12 13 14 15}

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

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 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]

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]

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]

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 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]

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]

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]

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 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 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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Can the results of live donor kidney transplantation be improved? [2004]

2. Turkey pubmed.ncbi.nlm.nih.gov

Preliminary Results of a Newly Established Organ Transplantation Program in a Teaching Hospital. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Preemptive kidney transplantation in patients with diabetes mellitus. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Short-Term Outcomes of 100 Consecutive Kidney Transplantations in a 3-Year Period: A Single-Center Experience. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety events in kidney transplant recipients: results from the folic Acid for vascular outcome reduction in transplant trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. [2019]

11. Iran pubmed.ncbi.nlm.nih.gov

Competitive Market Analysis of Transplant Centers and Discrepancy of Wait-Listing of Recipients for Kidney Transplantation. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Kidney transplantation in pediatric recipients with mental retardation: clinical results of a multicenter experience in Japan. [2011]

13. England pubmed.ncbi.nlm.nih.gov

Laboratory assessment of immune function in renal transplant patients. [2019]

14. France pubmed.ncbi.nlm.nih.gov

[Dual kidney transplant: the E. Herriot Hospital Lyon experience]. [2008]

15. United States pubmed.ncbi.nlm.nih.gov

Dialysis or transplant: an integrated approach to end-stage kidney disease management. [2005]