Reconstructed Kidney Transplants for Kidney Failure

Overseen By Mohamed Eltemamy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Insulin, Anti-hypertensives

Disqualifiers: Hypertension, Diabetes, Obesity, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to increase the number of available kidneys for transplant, aiding those with kidney failure. It involves using kidneys from donors who have had a small tumor removed, thus making these kidneys available for transplant. The trial seeks participants over 60 with severe kidney disease who lack a living donor and might not receive a kidney otherwise due to other health issues. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for kidney transplantation.

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. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that kidney transplants can be successful and safe, though they carry some risks. One study found that kidneys transplanted from living donors function well for a long time, with a success rate of 89%. This indicates that most transplanted kidneys work properly for many years.

However, kidney transplant patients might encounter some problems. These issues often relate to reduced kidney function and the medications required. While these medications help prevent the body from rejecting the new kidney, they can also cause side effects.

Overall, kidney transplants are generally well-tolerated, but understanding the possible risks and benefits is important. Discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment because it offers a novel approach to kidney transplantation for patients with kidney failure. Unlike standard kidney transplants that rely on healthy donor organs, this method involves using a kidney from a donor who has undergone a radical nephrectomy to remove a cT1a renal mass. By utilizing this reconstructed kidney, the treatment potentially increases the pool of available donor kidneys, which could significantly reduce waiting times for patients. This innovative technique not only maximizes the use of available organs but also provides an opportunity to transform a previously unusable kidney into a life-saving resource.

What evidence suggests that this trial's treatments could be effective for kidney failure?

Research has shown that kidney transplants, which participants in this trial may receive, effectively treat kidney failure. Recent studies indicate that 98.1% of kidney transplants from living donors function well after one year. Although about 20% of patients may lose transplant function within five years, most experience improved health and quality of life compared to other treatments. Notably, after the first year, only 3% of transplants fail annually. Overall, kidney transplants provide a promising solution for individuals with end-stage kidney disease. ^{6 7 8 9 10}

Who Is on the Research Team?

Mohamed Eltemamy, MD

Principal Investigator

Cleveland Clinic: Glickman Urological and Kidney Institute

Are You a Good Fit for This Trial?

This trial is for kidney cancer patients over 50 who can donate a kidney with a small tumor (≤4cm) and good renal function. Recipients must be over 60, have end-stage renal disease without other donor options, and not qualify for 'ideal' kidneys due to health or age.

Inclusion Criteria

For Donors: Adults > 50 years, willing and able to understand and sign informed consent, must have high-quality pre-operative cross-sectional imaging (CT or MRI) to determine tumor characteristics and perform parenchymal volume analysis for split renal function, candidate for partial nephrectomy for cT1a mass who understands that partial nephrectomy is standard of care for such mass but wishes to be an altruistic kidney donor via radical nephrectomy with loss of the entire kidney, normal baseline renal function with eGFR > 80 ml/min/1.73 m2, no proteinuria on urine dipstick, predicted new baseline GFR (NBGFR) following radical nephrectomy would be ≥ 45, tumor appears well-encapsulated, tumor appears amenable to ex-vivo partial nephrectomy with reconstruction that will leave ≥75% of the functioning parenchyma intact and well vascularized, low risk of complications for the recipient after ex-vivo PN based on surgeon judgment, tumor is cT1a which is defined as ≤ 4cm and confined, reconstructed kidney is likely to provide NBGFR for the recipient of >30 ml/min/1.73 m2, age >60 for Recipients, presence of ESRD or CKD5 with likely progression to ESRD, does not have potential living donor, not likely to receive a more 'ideal' donor kidney due to significant comorbidities and/or age

Exclusion Criteria

Criterion: Donors must not have certain health conditions such as familial RCC syndrome, being under 50 years of age, low kidney function, protein in the urine, high blood pressure needing three or more medicines, insulin-dependent diabetes, severe obesity, history of kidney stones, or certain characteristics of the kidney tumor. They must also meet the standard living donor selection process at the Cleveland Clinic and not have traditional contraindications to kidney transplantation at the Cleveland Clinic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo preoperative assessment and surveys regarding attitudes and decision-making surrounding kidney donation and transplantation

1-2 weeks

1 visit (in-person)

Surgery and Immediate Postoperative Care

Participants undergo radical nephrectomy and transplantation, with monitoring for peri-operative adverse events

4 weeks

Multiple visits (in-person) for surgery and immediate postoperative care

Intermediate Follow-up

Participants are monitored for surgical and functional outcomes, including adverse events and renal function

6 months

Regular visits (in-person) for monitoring

Long-term Follow-up

Participants are monitored for oncologic outcomes and renal function, with surveys on attitudes and decision-making

1 year

1 visit (in-person) at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Donor Radical and Partial Nephrectomy
• Kidney Transplantation
• Laparoscopic Radical Nephrectomy

Trial Overview

The study tests a new method where donors undergo radical nephrectomy to remove the entire kidney with the tumor. The tumor is then cut out ex-vivo, and the remaining healthy part of the kidney is transplanted into recipients.

How Is the Trial Designed?

Group I: cT1a Radical Nephrectomy + Donor Kidney Transplantation Experimental Treatment 3 Interventions

Radical nephrectomy will be used to remove a cT1a renal mass in an altruistic kidney donor. The kidney obtained from the radical nephrectomy participant with the cT1a mass removed will be transplanted to the recipient using an allograft.

Kidney Transplantation is already approved in United States, European Union for the following indications:

Approved in United States as Kidney Transplantation for:

• End-stage renal disease (ESRD) in HIV-positive patients

Approved in European Union as Kidney Transplantation for:

• Chronic kidney disease in HIV-positive patients
• End-stage renal disease (ESRD) in HIV-positive patients

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

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]

Citations

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Clinical outcomes of kidney transplantation from expanded ...

In this study, we demonstrated that the overall survival rate of grafts from ECD kidneys was significantly lower than that of grafts from SCD ...

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Kidney Transplant - Annual Data Report | USRDS - NIH

Adjusted 1-year graft survival among living donor kidney transplant recipients reached an all-time high of 98.1% for those transplanted in 2017 before dropping ...

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However, the US renal data system indicates that one in five patients will lose kidney transplant function within five years, and over half will face transplant ...

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Late graft failure after kidney transplantation as the ...

Beyond the first posttransplant year, 3% of kidney transplants fail annually. In a prospective, multicenter cohort study, we tested the relative impact of ...

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pmc.ncbi.nlm.nih.gov

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Impact of Transplantation Timing on Renal Graft Survival ...

No impact was observed of timing of graft surgery on graft survival with a median survival of 98 months and 132 months for daytime and nightime ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4469189/

Safety Events in Kidney Transplant Recipients

Kidney transplant recipients are at increased risk for adverse safety events related to their reduced renal function and many medications.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0966327423001387

Success rate and safety of living donor kidney ...

The overall long-term graft survival rate reported in the present study was 0.89 (95% CI: 0.75 to 0.96, P < 0.01; I2 = 92%) (Fig. 4). Meta-analysis of the ...

9.

nature.com

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Predicting graft and patient outcomes following kidney ...

This project uses interpretable methods to predict both graft failure and patient death using data from previously accepted kidney transplant offers.

10.

journals.lww.com

journals.lww.com/transplantjournal/fulltext/2020/06000/recipient_comorbidity_and_survival_outcomes_after.26.aspx

Recipient Comorbidity and Survival Outcomes After Kidney...

Overall, there were 134 “transplant failures” (85 graft failures and 49 patient deaths). The Kaplan-Meier estimate for 2-year transplant survival was 89.4% (95% ...