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Assessment of chronic renal allograft dysfunction with MRI: a pilot study

Assessment of chronic renal allograft dysfunction with MRI: a pilot study - ACRADYS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47430
Enrollment
50
Registered
2015-09-21
Start date
2017-12-14
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic allograft dysfunction 'interstitial fibrosis and tubular atrophy

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The main endpoint will be the degree of functional allograft damage. Differences between values of various MRI parameters (see *5.2 Study Procedures*) obtained in transplantation patients with and without chronic allograft dysfunction on the one hand, and between transplantation patients and healthy (control) volunteers on the other hand, will be analyzed.

Secondary

MeasureTime frame
The secondary endpoint will be the degree of structural allograft damage. This degree will be determined by analyzing the correlation between the best parameter (or combination of parameters) and the degree of IF/TA that was diagnosed in patients included in group A. Reproducibility of the scan protocol in patients.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)