Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney Candidates

NCT05717842 | Recruiting

• 1 other identifier: 15853
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant

Keywords

Liver; Kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To measure and correlate Clinical, laboratory and Radiographic data at the time of SLK transplant will be reviewed

  up to 100 weeks

Study Arms (1)

People with ESLD and eGFR between >=25 and <=40ml/min

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

Radiation: Nuclear Medicine Scan

Interventions

Nuclear Medicine Scan RADIATION

Mercaptoacetyltriglycine 3 (Mag 3) Nuclear Medicine Scan

People with ESLD and eGFR between >=25 and <=40ml/min

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \> 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Jerome A. Josephs Fund for Transplant Innovation Fund: collaborator

Study Sites (1)

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Central Study Contacts

Mary Balmes-Fenwick, B.S.

CONTACT

317-948-7772; mbalmes@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: February 8, 2023
• Study Start: December 8, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)