Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney Candidates

ConditionTransplant

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

> 18 years old

Listed for Liver Transplant for ESLD and Kidney Transplant (not on dialysis at time of transplant surgery)

Candidates with two native kidneys.

Willing to participate and sign informed consent form.

Disqualifiers

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

Prior history of any solid organ transplant.

Those who are currently pregnant or breast feeding.

Patients who have Autosomal Dominant polycystic kidney disease

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: People with ESLD and eGFR between >=25 and <=40ml/min1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

up to 100 weeks

Secondary outcomes

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.

Time frame

up to 100 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Jerome A. Josephs Fund for Transplant Innovation Fund

Collaborator

Source ClinicalTrials.gov

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