Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy (NCT05725421) | Clinical Trial Compass
RecruitingNot Applicable
Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy
United States5 participantsStarted 2023-09-08
Plain-language summary
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
Who can participate
Age range60 Years
SexALL
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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
* Patient who is a 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 (primary incentive is altruism) via radical nephrectomy with loss of the entire kidney.
* Functional considerations:
o Normal baseline renal function, with eGFR \> 80 ml/min/1.73 m2
* No proteinuria on urine dipstick (negative/trace considered negative)
* Predicted new baseline GFR (NBGFR) following radical nephrectomy would be ≥ 45
* NBGFR would be calculated using previously described equation based on split renal function (SFR) and renal functional compensation (RFC)
* NBGFR = global GFR x (SRFcontralateral from PVA) x 1.25 (average amount of RFC)2
* Tumor characteristics on pre-operative cross-sectional imaging:
* 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 N…
What they're measuring
1
Safety and Feasibility of Radical Nephrectomy for a Small Renal Mass
Timeframe: Within 30 days of surgery
2
Safety and feasibility for Renal Transplant Participants Receiving a Reconstructed Donor Kidney