Pathology and Imaging in Kidney Allografts | NCT03780101

Studies
Pathology and Imaging in Kidney Allografts

NCT03780101

Sponsor

NHS Greater Glasgow and Clyde

Status

Terminated

Last Update Posted

Jun 3, 2022Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Renal Transplant Rejection
Chronic Kidney Diseases
Fibrosis

Interventions

Multi-parametric renal MRI

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
248675	Other Identifier	IRAS project ID

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment difficulties due to impact of COVID-19 pandemic

Expanded Access Info

Start Date

Feb 15, 2019Actual

Primary Completion Date

May 24, 2022Actual

Completion Date

May 24, 2022Actual

First Submitted Date

Dec 17, 2018

First Submission Date that Met QC Criteria

Dec 17, 2018

First Posted Date

Dec 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2022

Last Update Posted Date

Jun 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will perform multi-parametric renal MRI in 70 patients with a renal transplant who are undergoing a clinically indicated biopsy of their transplant. The aim of this study is to compare findings on renal MRI with those seen on histology.

Detailed Description

Background: Renal transplantation is the optimal treatment for patients with renal failure. However, transplant life-span is finite and commonly limited due to the development of chronic rejection and other causes of irreversible fibrosis. At present, renal transplant biopsy is required to diagnose the cause of transplant dysfunction. Renal biopsies are invasive procedures that carry risks of bleeding, damage to the transplant and discomfort to patients. Functional magnetic resonance imaging (MRI) of the kidneys is an emerging field of research that has potential to non-invasively define and quantify parenchymal renal disease including fibrosis and inflammation. There is a paucity of data correlating multi-parametric renal MRI sequences with histological findings on biopsy, especially in patients with renal transplants.

Study participants: 70 adult renal transplant recipients who have been referred for a clinically indicated biopsy of their transplant kidney.

Study design: Participants will undergo multi-parametric renal MRI at time of biopsy. In patients who receive treatment for acute rejection, a second renal MRI will be undertaken at completion of treatment. Blood tests for fibrosis biomarkers and routine clinical measures of transplant function will be obtained at time of MRI scanning.

Objectives:

Assess the correlation between functional renal MRI sequences and histological markers of fibrosis and inflammation.
Assess the change in functional MRI sequences in response to treatment for acute rejection in renal transplant recipients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multi-parametric renal MRI	Diagnostic Test	Multi-parametric functional magnetic resonance imaging of a transplant kidney including sequences for T1, T2, diffusion-weighted imaging, diffusion tensor imaging and arterial spin labelling.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of MRI biomarkers for fibrosis with histology	Correlation between diffusion weighted imaging on renal MRI and reported percentage of cortical area on biopsy showing interstitial fibrosis.	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Renal MRI following treatment for acute rejection	Correlation between change in native T1 and serum creatinine following treatment for acute rejection.	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Recipient of a kidney transplant
Referred for clinically indicated biopsy of transplant kidney
Ability to comply with study procedures.
Ability to give informed consent.

Exclusion Criteria:

Any contraindication to MRI
Known pregnancy or intent to conceive during the study period
Clinical suspicion of delayed graft function as the cause of transplant dysfunction
Any other reason considered by a study physician to make the subject inappropriate for inclusion.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Renal transplant recipients referred for a clinically-indicated biopsy of their transplant kidney

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alastair J Rankin, MBChB	University of Glasgow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHS Greater Glasgow & Clyde		Glasgow			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D005355	Fibrosis

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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Browse Branches

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