Clinical trial NCT05717842: Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney Candidates
Official title: Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transplant
Keywords: Liver
Kidney
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Jerome A. Josephs Fund for Transplant Innovation Fund
First posted: 2023-02-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have end stage liver disease (ESLD) and kidney dysfunction, who are not on dialysis and have eGFR \>=25 and \<=40 ml/min for a duration of at least 6 weeks.

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:

Inclusion/Exclusion criteria:

Inclusion:

1. \> 18 years old
2. Listed for Liver Transplant for ESLD and Kidney Transplant based on eGFR ranging from ≥ 25 to ≤40 mL/min/1.73m2 (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 (e.g. 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.

Eligibility criteria: Inclusion Criteria:

1. \> 18 years old
2. Listed for Liver Transplant for ESLD and Kidney Transplant (not on dialysis at time of transplant surgery)
3. Candidates with two native kidneys.
4. Willing to participate and sign informed consent form.

Exclusion Criteria:

1. Unstable patients (e.g. in the ICU or those who are on Continuous Renal Replacement Therapy (CRRT) who cannot complete the nuclear medicine scan or those with AKI on Hemodialysis
2. Prior history of any solid organ transplant.
3. Those who are currently pregnant or breast feeding.
4. Patients who have Autosomal Dominant polycystic kidney disease

Primary outcomes:
measure: perform a nuclear medicine scan prior to SLK transplant
timeFrame: up to 100 weeks
Secondary outcomes:
measure: To measure and correlate Clinical, laboratory and Radiographic data at the time of SLK transplant will be reviewed
timeFrame: up to 100 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
Study officials:
References: