Mediators of Loin Pain in IgA Nephropathy

ConditionIgA Nephropathy (IgAN)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Leicester

About this trial

The goal of this observational study is to learn about loin pain in people with Immunoglobulin A nephropathy (IgAN).

The main question it aims to answer is:

What changes occur in the kidneys, urine, and blood when people with IgAN experience loin pain?

Participants will have MRI scans of their kidneys, provide urine and blood samples, and have their latest kidney function test results reviewed. For participants who experience loin pain, these assessments will be carried out during a pain episode and again when they are pain-free, so the results can be compared.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age at the time of recruitment

IgAN diagnosis confirmed with a renal biopsy

Episodic/Intermittent Loin Pain (defined as pain at least once every 6 months)

Have the capacity to consent to the study Cohort B

Disqualifiers

Constant loin pain

Infrequent loin pain (no pain experienced in the last 6 months)

Inability to differentiate loin pain from back pain

Other renal diseases

Trial population

The study population will include adults aged 18 years or over with a renal biopsy-confirmed diagnosis of Immunoglobulin A nephropathy (IgAN) who have capacity to provide informed consent. Participants will be recruited into two cohorts. Cohort A will include participants with IgAN who experience episodic or intermittent loin pain, defined as pain occurring at least once every 6 months. Cohort B will include participants with IgAN who have no history of loin pain. Participants will be excluded if they have another renal disease, are receiving therapies that may affect immune-mediated pathways, have received a kidney transplant, are receiving dialysis, are taking part in an interventional study that may affect kidney function, or have conditions or implants that are not compatible with MRI scanning.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants

are grouped into 2 trial groups

Group A: Cohort A: Loin pain group

Group B: Cohort B: No loin pain group

Trial outcomes

Primary outcomes

Change in MRI-derived total kidney volume between active pain and follow-up assessments in participants with episodic loin pain

Differences in total kidney volume (mL)

Time frame

Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.

Change in MRI-derived renal cortical volume between active pain and follow-up assessments in participants with episodic loin pain

Differences in renal cortical volume (mL)

Time frame

Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.

Change in MRI-derived renal medullary volume between active pain and follow-up assessments in participants with episodic loin pain

Differences in renal medullary volume (mL)

Time frame

Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.

Change in MRI-derived renal T1 relaxation time between active pain and follow-up assessments in participants with episodic loin pain

Difference in renal T1 relaxation time (ms)

Time frame

Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.

Secondary outcomes

Untargeted Liquid Chromatography-Tandem Mass spectrometry (LC-MS/MS) analysis to analyse differences in the urinary proteome between an active pain episode and when it subsides

Differences in abundance ratios

Time frame

Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit

Untargeted Liquid Chromatography-Tandem Mass spectrometry (LC-MS/MS) analysis to analyse the differences in the urinary proteome between pain-prone patients and those with no history of loin pain

Differences in abundance ratios

Time frame

Within 72 hours of pain onset for participants with episodic loin pain and baseline assessment after enrolment for participants with no history of loin pain.

Assessing the difference in molecules of interest between an active pain episode and when it subsides using enzyme-linked immunosorbent assay (ELISA) in urine, serum, and plasma

Differences in concentrations (w/v)

Time frame

Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit

Assessing the difference in molecules of interest between pain-prone patients and those who do not have a history of loin pain using enzyme-linked immunosorbent assay (ELISA) in urine, serum, and plasma.

Differences in concentrations (w/v)

Time frame

Within 72 hours of pain onset for participants with episodic loin pain and baseline assessment after enrolment for participants with no history of loin pain.

Other outcomes

Difference in estimated glomerular filtration rate between participants with episodic loin pain and participants with no history of loin pain

Difference in estimated glomerular filtration rate (mL/min/1.73 m²)

Time frame

Within the 12 months before or at enrolment

Sponsors and contacts

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

University of Leicester

Lead sponsor

University Hospitals, Leicester

Collaborator

Source ClinicalTrials.gov

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