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

Trial Summary

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.

What data supports the effectiveness of the treatment Reconstructed Kidney Transplants for Kidney Failure?

The research indicates that kidney transplantation has significantly improved short-term outcomes, with patient and graft survival rates between 92% and 95%. ^{1 2 3 4 5}

Is kidney transplantation generally safe for humans?

Kidney transplantation is generally considered safe, with high survival rates reported in both adults and children. For example, pediatric kidney transplants have 1- and 5-year patient survival rates of 98% and 94%, respectively, and adult transplants have similar positive outcomes, although there are risks like graft failure, infection, and other complications. ^{4 6 7 8 9}

How is the treatment 'Reconstructed Kidney Transplants' different from other treatments for kidney failure?

Reconstructed Kidney Transplants are unique because they focus on using a new kidney to replace a failed one, offering a chance for improved quality of life compared to dialysis, which is a common alternative. This treatment is particularly beneficial for patients who have experienced graft failure, as it aims to provide a more permanent solution than returning to dialysis. ^{4 9 10 11 12}

What is the purpose of this trial?

This study is designed to investigate a novel approach to offer more ESRD participants the benefits associated with renal transplantation by increasing the supply of available allografts

Research Team

Mohamed Eltemamy, MD

Principal Investigator

Cleveland Clinic: Glickman Urological and Kidney Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. 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]

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

Our evolving understanding of late kidney allograft failure. [2014]

3. Spain pubmed.ncbi.nlm.nih.gov

Dialysis after kidney transplant failure: do patients start in a worse condition than the general population with chronic kidney disease? [2015]

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

Perspectives and experiences of kidney transplant recipients with graft failure: A systematic review and meta-synthesis. [2023]

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

Medical care of kidney transplant recipients after the first posttransplant year. [2007]

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

Pediatric kidney transplantation. [2010]

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

Survival on dialysis post-kidney transplant failure: results from the Scientific Registry of Transplant Recipients. [2022]

8. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Renal transplantation at the jeddah kidney center. [2008]

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

Comorbid Conditions in Kidney Transplantation: Outcome Analysis at King Abdulaziz Medical City. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Challenges in the Management of the Patient with a Failing Kidney Graft: A Narrative Review. [2022]

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

Long-term outcome of kidney retransplantation in comparison with first kidney transplantation: a report from the Thai Transplantation Registry. [2013]

12. England pubmed.ncbi.nlm.nih.gov

Hemodialysis reinitiation using a resurrected mummy fistula: a case report. [2019]