Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney Candidates

Transplant Clinical Trial

— RECOVERY  

Official title:

Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717842
• Other study ID #: 15853
• Status: Recruiting
• Start date: December 8, 2023
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: Mary Balmes-Fenwick, B.S.
• Phone: 317-948-7772
• Email: mbalmes[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transplant

Intervention

Radiation:
• Nuclear Medicine Scan
Mercaptoacetyltriglycine 3 (Mag 3) Nuclear Medicine Scan

Locations

Country	Name	City	State
United States	IU Health University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Jerome A. Josephs Fund for Transplant Innovation Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perform a nuclear medicine scan prior to SLK transplant	To determine split kidney function with a Mag3 (Mercaptoacetyltriglycine 3) nuclear medicine renal scan as part of the study procedures.	up to 100 weeks
Secondary	To measure and correlate Clinical, laboratory and Radiographic data at the time of SLK transplant will be reviewed	This includes standard testing performed at our center prior to SLK transplant which are standard of care. This will include measurement of eGFR by Cystatin C.	up to 100 weeks