Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05717842
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2022-12-02
Brief Title:
Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney Candidates
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOVERY
Brief Summary:
The purpose of the study is to determine how much a persons kidney function recovers after receiving a simultaneous liver kidney transplant The investigators will be contacting patients with kidney dysfunction with estimated GFR between 25 and 40 not on dialysis treatment who are listed to receive a simultaneous liver kidney SLK transplant to look at this function recovery The investigators hope to develop a criteria based on GFR measurement kidney function calculations from native kidneys vs transplanted kidney and compare the contributions and correlate with estimated GFR on basic metabolic panel BMP a blood test to predict higher chances of recovery of native kidney function
Detailed Description:
Study design
Study will be a pilot longitudinal prospective study SLK transplant listed patients will be recruited from the outpatient Liver Kidney Transplant Clinic at Medical Diagnostic Clinic MDC as well as inpatients admitted to IU University Hospital Listing status for SLK transplant will be confirmed and patients will be scheduled for a Mag3 nuclear medicine scan at IU University Department of Nuclear medicine For study purposes this scan will be done pre and post-transplant to compare the results
Methods
InclusionExclusion criteria
Inclusion
1 18 years old
2 Listed for Liver Transplant for ESLD and Kidney Transplant based on eGFR ranging from 25 to 40 mLmin173m2 not on dialysis at time of surgery
3 Candidates with two native kidneys
4 Willing to participate and sign informed consent form
Exclusion Criteria
1 Unstable patients eg in the ICU or those who are on Continous Renal Replacement Therapy CRRT who cannot complete the nuclear medicine scan or those on Hemodialysis
2 Prior history of any solid organ transplant
3 Those who are currently pregnant or breast feeding
4 Patients with a history of Adult Polycystic Kidney Disease
Data collection Data collection will be done in RedCap These data forms will incorporate a comprehensive list of variables
1 Participants demographics and BMI
2 Reason for ESLD and complications listed in Medical Chart
3 Medication list
4 Results of Nuclear medicine scan eGFR on Basic Metabolic Panel measurement of eGFR by Cystatin C 24 hour urinary creatinine clearance and measurement of urinary NGAL level Radiographically kidney size presence of findings such as cysts stones etc
5 Post SLK transplant complications including need for Dialysis delayed graft function episodes of rejection infections and any reason for admission to the hospital
6 Adherent to Immunosuppression regimen and type of Immunosuppression regimen
7 BP readings at follow up clinic visits
8 Any post SLK transplant imaging for kidney size and any findings if any imaging is performed for any other indication none will done for the research study
Participants will be informed about the results of their studies Participation will be voluntary Compensation will be provided once in the form of 25 gift card that will be provided upon completing participation for the nuclear medicine scan 10 months after patients receive their SLK transplant Patients and their insurance will not be charged and the testing will be invoiced to the study grant
Provisions for post-study care No provision will be provided for care regarding incidental findings on the nuclear medicine scan They will be given information regarding referral to seeking appropriate care No expenses will be reimbursed for this care
Participant timeline
Enrollment of participants will be done starting February 2023 and completed by December 2023
Statistical Analyses
Sample size
Estimated number of participants is determined by participants listed for SLK transplant An estimated 15 participants are planned to be recruited As this is a pilot study all participants at IU will be asked to participate with a future goal of a multi-center study
Plans for assessment and collection of outcomes
Data will be collected in IU RedCap registry which is a secure platform Data will be entered in Redcap coded secured and stored Any raw data collection source documents will be kept in a locked cabinet in a locked office Data will be processed with SPSS data management software
Confidentiality Information about potential and enrolled participants will be collected shared and maintained in a manner that protects confidentiality before during and after the study
Study will be a pilot longitudinal prospective study SLK transplant listed patients will be recruited from the outpatient Liver Kidney Transplant Clinic at Medical Diagnostic Clinic MDC as well as inpatients admitted to IU University Hospital Listing status for SLK transplant will be confirmed and patients will be scheduled for a Mag3 nuclear medicine scan at IU University Department of Nuclear medicine For study purposes this scan will be done pre and post-transplant to compare the results
Methods
InclusionExclusion criteria
Inclusion
1 18 years old
2 Listed for Liver Transplant for ESLD and Kidney Transplant based on eGFR ranging from 25 to 40 mLmin173m2 not on dialysis at time of surgery
3 Candidates with two native kidneys
4 Willing to participate and sign informed consent form
Exclusion Criteria
1 Unstable patients eg in the ICU or those who are on Continous Renal Replacement Therapy CRRT who cannot complete the nuclear medicine scan or those on Hemodialysis
2 Prior history of any solid organ transplant
3 Those who are currently pregnant or breast feeding
4 Patients with a history of Adult Polycystic Kidney Disease
Data collection Data collection will be done in RedCap These data forms will incorporate a comprehensive list of variables
1 Participants demographics and BMI
2 Reason for ESLD and complications listed in Medical Chart
3 Medication list
4 Results of Nuclear medicine scan eGFR on Basic Metabolic Panel measurement of eGFR by Cystatin C 24 hour urinary creatinine clearance and measurement of urinary NGAL level Radiographically kidney size presence of findings such as cysts stones etc
5 Post SLK transplant complications including need for Dialysis delayed graft function episodes of rejection infections and any reason for admission to the hospital
6 Adherent to Immunosuppression regimen and type of Immunosuppression regimen
7 BP readings at follow up clinic visits
8 Any post SLK transplant imaging for kidney size and any findings if any imaging is performed for any other indication none will done for the research study
Participants will be informed about the results of their studies Participation will be voluntary Compensation will be provided once in the form of 25 gift card that will be provided upon completing participation for the nuclear medicine scan 10 months after patients receive their SLK transplant Patients and their insurance will not be charged and the testing will be invoiced to the study grant
Provisions for post-study care No provision will be provided for care regarding incidental findings on the nuclear medicine scan They will be given information regarding referral to seeking appropriate care No expenses will be reimbursed for this care
Participant timeline
Enrollment of participants will be done starting February 2023 and completed by December 2023
Statistical Analyses
Sample size
Estimated number of participants is determined by participants listed for SLK transplant An estimated 15 participants are planned to be recruited As this is a pilot study all participants at IU will be asked to participate with a future goal of a multi-center study
Plans for assessment and collection of outcomes
Data will be collected in IU RedCap registry which is a secure platform Data will be entered in Redcap coded secured and stored Any raw data collection source documents will be kept in a locked cabinet in a locked office Data will be processed with SPSS data management software
Confidentiality Information about potential and enrolled participants will be collected shared and maintained in a manner that protects confidentiality before during and after the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None