Renal Cell CarcinomaNCT05725421
Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy
A study testing Donor Radical and Partial Nephrectomy, Kidney Transplantation and Laparoscopic Radical Nephrectomy in people with Renal Cell Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Donor Radical and Partial Nephrectomy, Kidney Transplantation and Laparoscopic Radical Nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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 NBGFR for the recipient of >30 ml/min/1.73 m2. This can be estimated as (global GFR)(SRFipsilateral) x 0.75(estimate that at least 75% of the function will be saved during ex vivo tumor excision and reconstruction). Of note most such kidneys will experience some positive functional compensation but this might be mitigated by a small amount of functional loss related to ischemia. Most studies suggest that this will really be an underestimate of the final GFR in the recipient.
- For Recipients:
- Age >60
- Able to understand and willing to sign informed consent
- 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
Who cannot join
- 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)
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- 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:
- o Tumor has infiltrative features
- Tumor is > 4cm (does not meet criteria for cT1a stage)
- Regional lymphadenopathy, branch or main renal vein invasion, or other imaging findings suggestive of locally advanced disease
- Kidney characteristics on pre-operative cross-sectional imaging:
- More than one renal artery unless can be readily and safely reconstructed
- More than one renal vein unless can be readily and safely reconstructed
- Duplicated collecting system unless can be readily and safely reconstructed
- High-risk features on renal mass biopsy (if obtained) or intraoperative pathology
- o Malignant non-RCC pathology
- o Rhabdoid or sarcomatoid differentiation
- o Grade 4
- o Positive or concerning margins during tumor excision
- Must be deemed appropriate living donor candidate per the standard living donor selection process at the Cleveland Clinic o All altruistic living donors undergo a complete evaluation by medical providers and social workers ensuring that they are appropriate candidates to undergo this procedure. This evaluation includes direct query into any history of psychiatric comorbidities and/or substance abuse. If present, this prompts a formal evaluation by psychiatry prior to confirmation of donor candidacy.
- For Recipients:
- Traditional contraindications to kidney transplantation at the Cleveland Clinic would apply, including the following directly from the Transplant Care Pathway:
- Active, untreated bacterial, fungal, or viral infections. Once treated, patients may be reconsidered. Patients with human immunodeficiency virus (HIV)14 or chronic hepatitis15 infections will be evaluated on an individual basis.
- Active malignancy, except non-melanoma skin cancer and other selected low-grade, low-stage cancers (e.g., bladder, kidney, prostate). The American Society of Transplant (AST) clinical practice guidelines published in 2001 are dated. Improved methods of cancer prognostication are available on a cancer-specific basis.16 An acceptable disease-free waiting period may be needed prior to transplantation depending on the cancer type (stage/grade) and treatment modality. Expert opinion from an oncological specialist may be needed to facilitate decisions about wait-listing or performance of a transplant.
- Medical non-adherence, substance abuse or behaviors leading to a failure to achieve a therapeutic physician/transplant team-patient alliance.
- Life expectancy of less than five years independent of renal disease.
- Advanced circulatory disease (cardiac, cerebral, peripheral), pulmonary disease or other non-renal conditions such that transplantation would pose a significant risk for morbidity/mortality.
- Obesity with body mass index (BMI) > 38, or an abdominal wall configuration that in the judgment of the evaluating surgeon poses undue complication risk.
- Active nicotine abuse (in any form).
- Poor functional status independent of renal disease.
- Considering the average waiting times for a deceased donor kidney is more than 3 years, only transplant candidates 72 years or younger will be accepted for evaluation. Suitable candidates may remain on the waiting list up to the age of 75-year-old. They will be delisted if no transplantation has occurred.
- Cumulative burden of disease defined as multiple medical conditions that on their own may not preclude listing but that in combination are deemed not suitable by the transplant selection committee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Mohamed Eltemamy, MD, 216-296-3693, Eltemam@ccf.org
Mohamed Eltemamy, MD
About this study
Official title: Oncologic, Functional and Surgical Outcomes for Patients Undergoing Radical Nephrectomy for Low-Risk Renal Cell Carcinoma and Recipients of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy
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
- Being tested
- Donor Radical and Partial Nephrectomy, Kidney Transplantation, Laparoscopic Radical Nephrectomy
- Keywords
- Radical Nephrectomy, Renal Allograft, Ex-Vivo Partial Nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor Radical and Partial NephrectomyProcedure or surgery
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).
Kidney TransplantationProcedure or surgery
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.
Laparoscopic Radical NephrectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Donor Radical and Partial Nephrectomy; Procedure: Kidney Transplantation; Procedure: Laparoscopic Radical Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Anemia ii. Acute kidney injury
Measured: 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:
- Anemia ii. Renal hemorrhage iii. Kidney anastomotic leak iv. Urinary fistula
Measured: Within 30 days of surgery
Secondary outcomes (8)
Surgical Outcomes for a Radical Nephrectomy for a Small Renal Mass
- Intermediate term surgical outcomes as determined by adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 180 days of surgery: i. Anemia ii. Acute kidney injury iii. Wound infection iv. Infection and infestations - Urinary tract infection, abscess
Measured: Within 180 days of surgery
Functional Outcomes for a Radical Nephrectomy for a Small Renal Mass
Renal function as determined by:
- Post-operative baseline GFR >45 ml/min/1.73m2 at time of follow up ii. GFR >45 ml/min/1.73m2 at one year after radical nephrectomy
Measured: 1 year after surgery
Oncologic Outcomes for a Radical Nephrectomy for a Small Renal Mass
- Oncologic outcomes as determined by local or distant recurrence of malignancy within one year of follow up
Measured: Up to 1 year after surgery
Surgical Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
Intermediate term surgical outcomes as determined by adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 180 days of surgery:
- Anemia ii. Renal hemorrhage iii. Kidney anastomotic leak iv. Urinary fistula v. Wound infection vi. Infection and infestations - Other, Urinary tract infection, abscess, bacteremia
Measured: Within 180 days of surgery
Functional Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
Renal function as determined by:
- Delayed-graft function ii. Nadir post-transplant GFR iii. GFR measured at one year follow up
Measured: 1 year after surgery
Oncologic Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
- Oncologic outcomes as determined by local or distant recurrence of malignancy within one year of follow up, diagnosed by one year follow up CT imaging or other method used to determine presence of recurrent malignancy
Measured: Up to 1 year after surgery
Participant Attitudes/Decision Making Surrounding Altruistic Kidney Donation
Participant attitudes and decision making surrounding altruistic donation as a component of surgery for a renal mass will be determined by a survey provided to participants at a preoperative visit prior to surgery and at the 12 month follow-up visit.
Measured: 1 year after surgery
Participant Attitudes/Decision Making Surrounding Transplant Recipients
Participant attitudes and decision-making surrounding receipt of a kidney that previously had a small renal mass will be determined by a survey provided to participants at a preoperative visit prior to surgery and at the 12-month follow-up visit.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Eltemamy, MD, Principal investigator, Cleveland Clinic: Glickman Urological and Kidney Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725421
- Sponsor's protocol ID
- CASE13822
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic, Functional and Surgical Outcomes for Patients Undergoing Radical Nephrectomy for Low-Risk Renal Cell Carcinoma and Recipients of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT05725421
- Acronym / sponsor ID
- CASE13822
- Conditions
- Renal Cell Carcinoma
- Keywords
- Radical Nephrectomy, Renal Allograft, Ex-Vivo Partial Nephrectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cT1a Radical Nephrectomy + Donor Kidney Transplantation | Experimental | Procedure: Donor Radical and Partial Nephrectomy, Procedure: Kidney Transplantation, Procedure: Laparoscopic Radical NephrectomyRadical 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
Key exclusion criteria (40 listed)
- Known familial RCC syndrome
- Functional considerations:
- o < 50 years of age
- Comorbidities with risk of deteriorating renal function:
- Tumor characteristics on pre-operative cross-sectional imaging:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donor Radical and Partial NephrectomyDonor 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). | Procedure or surgery | cT1a Radical Nephrectomy + Donor Kidney Transplantation |
| Kidney TransplantationThe 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. | Procedure or surgery | cT1a Radical Nephrectomy + Donor Kidney Transplantation |
| Laparoscopic Radical NephrectomyRadical 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. | Procedure or surgery | cT1a Radical Nephrectomy + Donor Kidney Transplantation |
Primary outcome
Safety and Feasibility of Radical Nephrectomy for a Small Renal Mass
Time frame: Within 30 days of surgery
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
Safety and feasibility for Renal Transplant Participants Receiving a Reconstructed Donor Kidney
Time frame: Within 30 days of surgery
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
8 secondary outcomes
Surgical Outcomes for a Radical Nephrectomy for a Small Renal Mass
Time frame: Within 180 days of surgery
Functional Outcomes for a Radical Nephrectomy for a Small Renal Mass
Time frame: 1 year after surgery
Oncologic Outcomes for a Radical Nephrectomy for a Small Renal Mass
Time frame: Up to 1 year after surgery
Surgical Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
Time frame: Within 180 days of surgery
Functional Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
Time frame: 1 year after surgery
Oncologic Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
Time frame: Up to 1 year after surgery
Participant Attitudes/Decision Making Surrounding Altruistic Kidney Donation
Time frame: 1 year after surgery
Participant Attitudes/Decision Making Surrounding Transplant Recipients
Time frame: 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Eltemamy, MD principal investigator
Cleveland Clinic: Glickman Urological and Kidney Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donor Radical and Partial Nephrectomy, Kidney Transplantation and Laparoscopic Radical Nephrectomy in people with Renal Cell Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Eltemamy, MD (216-296-3693, Eltemam@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Feasibility of Radical Nephrectomy for a Small Renal Mass (time frame: Within 30 days of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.