- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05717842
Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney Candidates (RECOVERY)
Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney
Study Overview
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:
- > 18 years old
- 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)
- Candidates with two native kidneys.
- Willing to participate and sign informed consent form.
Exclusion Criteria:
- 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
- Prior history of any solid organ transplant.
- Those who are currently pregnant or breast feeding.
- 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:
- Participants demographics and BMI
- Reason for ESLD and complications listed in Medical Chart
- Medication list
- 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.
- Post SLK transplant complications including need for Dialysis, delayed graft function, episodes of rejection, infections and any reason for admission to the hospital
- Adherent to Immunosuppression regimen, and type of Immunosuppression regimen
- BP readings at follow up clinic visits
- 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mary Balmes-Fenwick, B.S.
- Phone Number: 317-948-7772
- Email: mbalmes@iu.edu
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- IU Health University Hospital
-
Principal Investigator:
- Muhammad Y Jan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- > 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
People with ESLD and eGFR between >=25 and <=40ml/min
|
Mercaptoacetyltriglycine 3 (Mag 3) Nuclear Medicine Scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
perform a nuclear medicine scan prior to SLK transplant
Time Frame: up to 100 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure and correlate Clinical, laboratory and Radiographic data at the time of SLK transplant will be reviewed
Time Frame: up to 100 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Transplant
-
University Health Network, TorontoNot yet recruitingSolid Organ Transplant | Liver Transplant | Kidney Transplant | Heart Transplant
-
Liverpool University Hospitals NHS Foundation TrustKidney Research United KingdomNot yet recruitingFrailty | Kidney Transplant Rejection | Renal Transplant | Diagnosis | Kidney Transplant; Complications | Kidney Transplant | Renal Transplant Failure | Transplant DysfunctionUnited Kingdom
-
Hopital FochRecruitingLung Transplant Rejection | Lung Transplant Failure | Lung Transplant; Complications | Lung Transplant Failure and RejectionFrance
-
University of MinnesotaCompletedKidney Transplant Rejection | Kidney Transplant; Complications | Transplant; Complication, Rejection | Kidney Transplant Failure and Rejection | Transplant DysfunctionUnited States
-
University of MinnesotaWithdrawnKidney Transplant Rejection | Kidney Transplant; Complications | Kidney Transplant FailureUnited States
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)TerminatedLiver Transplant | Kidney TransplantUnited States
-
Astellas Pharma Europe Ltd.CompletedLiver Transplant | Kidney TransplantItaly, Spain, Belgium, Germany, Latvia, Canada, Korea, Republic of, Czechia, Austria, Finland, Belarus, Estonia, France, Hungary, Ireland, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Sweden, Switzerland, United...
-
Stanley Jordan, MDActive, not recruitingKidney Transplant Rejection | Kidney Transplant; Complications | Antibody-mediated Rejection | Transplant Glomerulopathy | Transplant Glomerulopathy - Late Form | Transplant Glomerulopathy - Early FormUnited States
-
National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)CompletedKidney Transplantation | Renal Transplant | Renal Transplantation | Transplant Rejection | Transplant ToleranceUnited States
-
Alp SenerNot yet recruitingRenal Transplant | Kidney Transplant
Clinical Trials on Nuclear Medicine Scan
-
M.D. Anderson Cancer CenterTerminatedAdvanced CancersUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Lymphoma | Advanced Malignant Solid Neoplasm | Refractory Lymphoma | Refractory Malignant Solid Neoplasm | Refractory Multiple Myeloma | Hematopoietic and Lymphatic System NeoplasmUnited States
-
University Hospital, Strasbourg, FranceRecruitingPulmonary EmbolismFrance
-
Singapore General HospitalNational Heart Centre Singapore; National Medical Research Council (NMRC),...Completed
-
National Cancer Institute (NCI)Active, not recruitingMalignant Solid Neoplasm | Recurrent Melanoma | Recurrent Ependymoma | Recurrent Ewing Sarcoma | Recurrent Hepatoblastoma | Recurrent Langerhans Cell Histiocytosis | Recurrent Malignant Germ Cell Tumor | Recurrent Malignant Glioma | Recurrent Medulloblastoma | Recurrent Neuroblastoma | Recurrent Non-Hodgkin... and other conditionsUnited States, Puerto Rico
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Lymphoma | Advanced Malignant Solid Neoplasm | Refractory Lymphoma | Refractory Malignant Solid Neoplasm | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Advanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Recurrent Hepatoblastoma | Recurrent Langerhans Cell Histiocytosis | Recurrent Malignant Glioma | Recurrent Malignant Solid Neoplasm | Recurrent Neuroblastoma and other conditionsUnited States, Puerto Rico
-
National Cancer Institute (NCI)Children's Oncology GroupActive, not recruitingRefractory Lymphoma | Refractory Malignant Solid Neoplasm | Recurrent Ependymoma | Recurrent Ewing Sarcoma | Recurrent Hepatoblastoma | Recurrent Histiocytic and Dendritic Cell Neoplasm | Recurrent Langerhans Cell Histiocytosis | Recurrent Lymphoma | Recurrent Malignant Germ Cell Tumor | Recurrent Malignant... and other conditionsUnited States, Puerto Rico, Australia
-
The Affiliated Hospital Of Guizhou Medical UniversityActive, not recruitingIntracerebral HemorrhageChina
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Recurrent Ependymoma | Recurrent Hepatoblastoma | Recurrent Langerhans Cell Histiocytosis | Recurrent Malignant Germ Cell Tumor | Recurrent Malignant Glioma | Recurrent Malignant Solid Neoplasm | Recurrent Medulloblastoma | Recurrent... and other conditionsUnited States, Puerto Rico