NL-OMON47430CompletedNot Applicable
Assessment of chronic renal allograft dysfunction with MRI: a pilot study - ACRADYS
niversitair Medisch Centrum Utrecht0 sites50 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Group A (n=15):
- •Patients have undergone at least one kidney transplantation procedure;Patients are 18 year or older;Patients are currently suspect for CAD at the time of inclusion (CAD is defined as a clinical diagnosis characterized by deterioration of kidney function in any way (e.g. increase in SCr, new proteinuria) that demands further diagnostic evaluation; Kidney biopsy is performed according to the existing guidelines for clinical practice just prior to or shortly after the MRI-scan has been performed (time in between the events < 2 weeks) ;Time between NTx and inclusion must be at least 6 months,Patients volunteer to participate and are capable and prepared to sign an informed consent.;Group B (n=20):
- •Volunteers have undergone at least one kidney transplantation procedure; Volunteers are 18 year or older; volunteers have a well-functioning allograft and are not showing any clinical signs of allograft dysfunction; Time between NTx and inclusion is at least 3 months; Volunteers are capable and prepared to sign an informed consent;Group C1 (n=15 - x):
- •Volunteers have donated a kidney to someone that is included in group A or B; Volunteers are 18 year or older; Volunteers are not altruistic kidney donor; Volunteers are not diagnosed with any renal disease; Volunteers are prepared to give a blood sample for analysis of the SCr; Volunteers are capable and prepared to sign an informed consent.;Group C2 (n=x):
- •Volunteers are 18 year or older; Volunteers are not diagnosed with any renal disease; Volunteers are prepared to give a blood sample for analysis of the SCr; Volunteers are capable and prepared to sign an informed consent; Volunteers can be sex- and age matched within a range of 5 years to patients in group A/B1 (who are not already matched to their donor). Part of the volunteer data will consist of data from volunteers who are already scanned for another study (ReMARK, METC NL45144.041.13, 13/402) under the same conditions with the same scan protocol.
Exclusion Criteria
- •Volunteers with contra-indications for MRI (like a pacemaker, an internal prosthesis or claustrophobia); Refusal of volunteers to be informed of chance findings possibly relevant to their health; Pregnancy.
Investigators
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