Actively Recruiting
Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy
Led by Case Comprehensive Cancer Center · Updated on 2026-03-16
5
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Donors must be adults over 50 years old
- Donors must be willing and able to understand and sign informed consent
- Donors must have high-quality pre-operative imaging (CT or MRI) to evaluate tumor and kidney function
- Donors must be candidates for partial nephrectomy for a cT1a mass and willing to undergo radical nephrectomy as altruistic donors
- Donors must have normal baseline kidney function with eGFR greater than 80 ml/min/1.73 m2
- Donors must have no proteinuria on urine dipstick (negative or trace only)
- Predicted new baseline GFR after radical nephrectomy must be at least 45 ml/min/1.73 m2
- Tumor must appear well-encapsulated and suitable for ex-vivo partial nephrectomy preserving at least 75% of functioning kidney tissue
- Tumor size must be 4 cm or smaller and confined (cT1a)
- Reconstructed kidney must likely provide recipient GFR over 30 ml/min/1.73 m2
- Recipients must be 60 years or older
- Recipients must be able to understand and willing to sign informed consent
- Recipients must have ESRD or CKD stage 5 likely to progress to ESRD
- Recipients must not have a potential living donor
- Recipients likely will not receive a more ideal donor kidney due to age or significant health problems
You will not qualify if you...
- Donors with known familial renal cell carcinoma syndrome
- Donors younger than 50 years old
- Donors with preoperative GFR less than 80 ml/min/1.73 m2
- Donors with proteinuria (1+ or higher on urine dipstick or urinalysis)
- Predicted new baseline GFR after radical nephrectomy less than 45 ml/min/1.73 m2
- Donors with hypertension requiring three or more medications
- Donors with insulin-dependent diabetes or diabetes with organ damage
- Donors with morbid obesity
- Donors with history of kidney stones or other kidney problems
- Tumors with infiltrative features or larger than 4 cm
- Tumors with lymph node involvement or renal vein invasion
- Kidneys with more than one artery or vein unless safely reconstructed
- Kidneys with duplicated collecting system unless safely reconstructed
- Tumors with high-risk pathology such as non-renal cell carcinoma malignancies, rhabdoid or sarcomatoid differentiation, grade 4 tumors, or positive surgical margins
- Donors who are not appropriate living donor candidates after medical and social evaluation
- Recipients with active untreated infections
- Recipients with active malignancy except certain low-risk skin or organ cancers
- Recipients with poor adherence, substance abuse, or behaviors interfering with medical care
- Recipients with life expectancy less than five years
- Recipients with advanced heart, brain, lung, or other conditions increasing transplant risk
- Recipients with BMI over 38 or abdominal anatomy posing surgical risk
- Recipients who actively use nicotine
- Recipients with poor functional status unrelated to kidney disease
- Recipients older than 72 at evaluation or older than 75 on waiting list without transplant
- Recipients with multiple combined medical conditions deemed unsuitable for transplant by selection committee
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
M
Mohamed Eltemamy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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