Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy

NCT05725421 | Recruiting

• 1 other identifier: CASE13822
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Renal Cell Carcinoma

Keywords

Radical Nephrectomy; Renal Allograft; Ex-Vivo Partial Nephrectomy

Outcome Measures

Primary Outcomes (2)

• Safety and Feasibility of Radical Nephrectomy for a Small Renal Mass

  Safety and feasibility as determined by peri-operative adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 30 days of surgery: i. Anemia ii. Acute kidney injury

  Within 30 days of surgery

• Safety and feasibility for Renal Transplant Participants Receiving a Reconstructed Donor Kidney

  Safety and feasibility as determined by peri-operative adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 30 days of surgery: i. Anemia ii. Renal hemorrhage iii. Kidney anastomotic leak iv. Urinary fistula

  Within 30 days of surgery

Secondary Outcomes (8)

• Surgical Outcomes for a Radical Nephrectomy for a Small Renal Mass

  Within 180 days of surgery

• Functional Outcomes for a Radical Nephrectomy for a Small Renal Mass

  1 year after surgery

• Oncologic Outcomes for a Radical Nephrectomy for a Small Renal Mass

  Up to 1 year after surgery

• Surgical Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy

  Within 180 days of surgery

• Functional Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy

  1 year after surgery

Study Arms (1)

cT1a Radical Nephrectomy + Donor Kidney Transplantation

EXPERIMENTAL

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.

Procedure: Donor Radical and Partial Nephrectomy; Procedure: Kidney Transplantation; Procedure: Laparoscopic Radical Nephrectomy

Interventions

Donor Radical and Partial Nephrectomy PROCEDURE

Donor participants will undergo laparoscopic radical nephrectomy (RN) . Donor kidney then will undergo cold perfusion and ex-vivo partial nephrectomy (PN) with cold ischemia. During PN, careful inspection of tumor will be performed to ensure it is well-encapsulated. If any infiltrative features (versus well encapsulated tumor) are noted intraoperatively then transplant will not be performed. Multiple surgical margins will be sent (either frozen section or standard with priority). If final margins are positive or concerning, then transplant will not be performed. Biopsies of the tumor will be performed and sent to pathology (either frozen section or standard with priority).

cT1a Radical Nephrectomy + Donor Kidney Transplantation

Kidney Transplantation PROCEDURE

The donor kidney will remain on ice while pathologic analysis is performed, and transplant recipient surgery is initiated (if pathologic analysis satisfactory). Cold ischemia with delay for pathology will have minimal functional impact in this setting based on extensive prior experience with renal transplantation where kidneys are routinely kept hypothermic for several hours prior to transplantation.

cT1a Radical Nephrectomy + Donor Kidney Transplantation

Laparoscopic Radical Nephrectomy PROCEDURE

Radical nephrectomy consists of the removal of the kidney together with the perirenal fat and regional lymph nodes. The transperitoneal approach allows early control of the renal vessels.

cT1a Radical Nephrectomy + Donor Kidney Transplantation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• For Donors:
• Known familial RCC syndrome
• Functional considerations:
• o \< 50 years of age
• Preoperative GFR \< 80 ml/min/1.73 m2
• Proteinuria on urine dipstick or urinalysis (≥1+ considered positive)
• 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
• Comorbidities with risk of deteriorating renal function:
• Hypertension requiring three or more anti-hypertensives
• Diabetes mellitus requiring insulin or with end organ damage
• Morbid obesity
• History of nephrolithiasis or other
• Tumor characteristics on pre-operative cross-sectional imaging:

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Mohamed Eltemamy, MD

  Cleveland Clinic: Glickman Urological and Kidney Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Eltemamy, MD

CONTACT

216-296-3693; Eltemam@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: September 8, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)