Multi-Parametric MRI for Renal Transplantation

ConditionRenal Transplant Rejection

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorUniversity of Minnesota

About this trial

The goals of this study are:

* To optimize and evaluate multiple kidney MRI methods; and * To investigate the potential of MRI in the assessment of transplant kidney functions; To achieve these goals, we will perform pilot MRI studies with kidney transplant patients. We will study if MRI can reflect different levels of kidney function. The investigators will also evaluate if MRI can differentiate causes for declining kidney function. Finally, the investigators will explore how MRI measures changes before and after medical treatment for worsening kidney function.

You may be invited for MRI exams with different exam options. An MRI exam may use either of two types of MRI machines at the center for magnetic resonance research (CMRR): the 3 Tesla (3T) scanner and the 7 Tesla (7T) scanner. You may also be invited for a multi-session exam. A description of the MRI exam types with different exam options and the types of multi-session exams is provided later in this document.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Renal Transplant Recipients

Capable to consent

English speaking

For studies with patients with fast worsening renal function: An abrupt (within 48 h) reduction in kidney function currently defined as a percentage increase in serum creatinine of ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria of less than 0.5 mL/kg/h for more than 6 h).

Disqualifiers

On dialysis due to renal allograft failure

Acute and chronic pulmonary disease

Pregnancy as reported in CMRR Safety Screen

Ferromagnetic implants

Trial population

The proposed studies are pilot studies to obtain preliminary data for the development of hypotheses and estimate the power for future large-scale studies. To accomplish the objectives of the proposed pilot studies, we will enroll a total of 140 renal transplant patients. Based on our previous experience, there will be about 20% patients who may withdraw after informed consent. Equal number of male and female subjects will be recruited for each patient group. In addition, the age of patients will be matched or ensured insignificant across the groups of the study objectives.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Magnetic Resonance Imaging
Device
Investigate anatomic and functional characteristics of transplant kidneys using MRI

Treatment groups

140 Participants

are divided into 2 treatment groups

Group A: Patients with Stable Renal Function1 intervention

Group B: Patients with Worsening Renal Function due to complications1 intervention

Trial outcomes

Primary outcomes

Anatomic and functional MRI characteristics in transplant kidneys with stable renal function

Investigate the correlations between anatomic and functional characteristics by MRI and the level of transplant renal function

Time frame

Baseline

Secondary outcomes

Anatomic and functional MRI characteristics of transplant kidneys with transplant complications

Investigate the anatomic and functional MRI characteristics of transplant kidneys with transplant complications with comparisons with those from transplant kidneys having stable renal function

Time frame

Baseline

Sponsors and contacts

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

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: