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Procedure
Reconstructed Kidney Transplants for Kidney Failure
N/A
Waitlist Available
Led By Mohamed Eltemamy, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of surgery
Awards & highlights
Study Summary
This trial explores a way to expand the number of available kidneys to give more people with kidney failure the chance to get a transplant.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include complications from surgery such as bleeding or infection, adverse reactions to anesthesia, issues related to reduced kidney function in donors post-surgery, and transplant rejection or dysfunction in recipients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Feasibility of Radical Nephrectomy for a Small Renal Mass
Safety and feasibility for Renal Transplant Participants Receiving a Reconstructed Donor Kidney
Secondary outcome measures
Functional Outcomes for a Radical Nephrectomy for a Small Renal Mass
Functional Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
Oncologic Outcomes for a Radical Nephrectomy for a Small Renal Mass
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: cT1a Radical Nephrectomy + Donor Kidney TransplantationExperimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kidney Transplantation
2008
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,905 Total Patients Enrolled
Mohamed Eltemamy, MDPrincipal InvestigatorCleveland Clinic: Glickman Urological and Kidney Institute
2 Previous Clinical Trials
318 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.
Research Study Groups:
This trial has the following groups:- Group 1: cT1a Radical Nephrectomy + Donor Kidney Transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial actively seeking participants at present?
"According to clinicaltrials.gov, this trial has completed its recruitment process and is not welcoming any further candidates at present. Initially posted on July 1st 2023 and edited most recently February 15th 2023, there are however over 2500 other trials seeking participants immediately."
Answered by AI
What outcomes is this study attempting to manifest?
"The central aim of this trial, which will be evaluated within a month after the surgery, is to assess safety and efficacy for those undergoing renal transplantations using a reconstructed donor kidney. Secondary objectives include assessing functional outcomes post-radical nephrectomy (such as GFR at follow up/one year), oncologic results in terms of recurrence rate, and intermediate term surgical outcomes such as anemia or infection rates."
Answered by AI
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