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Enrolling by invitationNCT07649538LO-PAIgNUpdated Oct 20, 2026

Mediators of Loin Pain in IgA Nephropathy

An observational study in IgA Nephropathy (IgAN), sponsored by University of Leicester. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by University of Leicester · Observational

Updated Oct 20, 2026Now Enrolling by invitationStudy documents posted+1 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Some people with Immunoglobulin A nephropathy (IgAN) experience loin pain, or pain around the kidneys, but the underlying cause of this pain is not well understood. Current treatment options often do not provide effective pain relief, and a better understanding of the mechanisms involved may support the development of more targeted treatments in the future and help understand what this pain may mean for the disease state.

This observational study will investigate whether loin pain in IgAN is associated with changes in the kidneys, kidney function, and biological markers in blood and urine. Participants will undergo magnetic resonance imaging (MRI) of the kidneys to assess whether there are structural or tissue-related differences during episodes of pain compared with pain-free periods. The study will also assess the renal pelvis, the urine-collecting part of the kidney, to explore whether it may be involved in the development of pain.

Blood and urine samples will be collected to investigate whether biological molecules differ during pain episodes and pain-free periods. Urine samples will also be examined under the microscope to assess for the presence of blood cells or other features that may suggest kidney injury or inflammation.

Participants' most recent kidney function test results will also be reviewed to explore whether kidney function is associated with the presence or severity of loin pain. Together, these assessments aim to provide a better understanding of what happens in the kidneys and biological samples of people with IgAN when they experience loin pain.

02

Conditions studied

  • IgA Nephropathy (IgAN)

Keywords

  • Kidney pain
  • IgAN
  • IgA nephropathy
  • Flank pain
  • Loin pain
  • Renal pain
03

In context

Glomerulonephritis, IGA

275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.

This study's planned enrollment of 40 is below the median of 245 across 45 observational studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

University of Leicester is the lead sponsor of 170 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Cohort A

  1. ≥18 years of age at the time of recruitment
  2. IgAN diagnosis confirmed with a renal
  3. Episodic/Intermittent Loin Pain (defined as pain at least once every 6 months)
  4. Have the capacity to consent to the study Cohort B

1) ≥18 years of age at the time of recruitment 2) IgAN diagnosis confirmed with a renal biopsy 3) No history of loin pain 4) Have the capacity to consent to the study

Exclusion criteria

Exclusion Criteria:

Cohort A

  1. Constant loin pain
  2. Infrequent loin pain (no pain experienced in the last 6 months)
  3. Inability to differentiate loin pain from back pain
  4. Other renal diseases
  5. Therapies that interfere with immune-mediation like and complement inhibitors
  6. Kidney transplant recipients
  7. Current participation in an interventional study that may affect kidney function
  8. Patients on dialysis
  9. Patients with implants that are not MRI-safe (pacemakers, implantable defibrillators, cochlear implants, some shunts, neurostimulators, some aneurysm clips, etc.)

Cohort B

  1. Other renal diseases
  2. Therapies that interfere with immune-mediation like steroids and complement inhibitors
  3. Kidney transplant recipients
  4. Current participation in an interventional study that may affect kidney function
  5. Patients on dialysis
  6. Patients with conditions/implants that are not MRI-compatible (claustrophobia, pacemakers, implantable defibrillators, cochlear implants, some shunts, neurostimulators, some aneurysm clips, etc.)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Cohort A: Loin pain group

    This group would consist of patients with IgAN who experience loin pain episodes

  • Cohort B: No loin pain group

    This group would consist of patients with IgAN who have never experienced loin pain

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Presence of renal pelvis abnormality on renal MRI in participants with episodic loin pain and participants with no history of loin pain

    Presence of renal pelvis abnormality, including renal pelvis dilatation

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

  6. Difference in MRI-derived total kidney volume between participants with episodic loin pain and participants with no history of loin pain

    Difference in total kidney volume (mL)

    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.

  7. Difference in MRI-derived renal cortical volume between participants with episodic loin pain and participants with no history of loin pain

    Difference in renal cortical volume (mL)

    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.

  8. Difference in MRI-derived renal medullary volume between participants with episodic loin pain and participants with no history of loin pain

    Difference in renal medullary volume (mL)

    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.

  9. Difference in MRI-derived renal T1 relaxation time between participants with episodic loin pain and participants with no history of loin pain

    Difference in T1 relaxation time (ms)

    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.

  10. Assessment of organ-level changes between pain-prone patients and those with no history of loin pain using structural renal magnetic resonance imaging (MRI)

    Presence of renal pelvis abnormality, including renal pelvis dilatation

    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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. Comparing the presence of urinary factors that indicate active intra-renal injury between an active pain episode and when it subsides using urine microscopy

    Difference in abundance (count per high magnification field)

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

  6. Comparing the presence of urinary factors that indicate active intra-renal injury between an pain-prone patients and those with no history of loin pain using urine microscopy

    Difference in abundance (count per high magnification field)

    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.

  7. Comparing the presence of urinary factors that indicate active intra-renal injury between an active pain episode and when it subsides using the urine dipstick test

    Difference in presence (Yes/No)

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

  8. Comparing the presence of urinary factors that indicate active intra-renal injury between an pain-prone patients and those with no history of loin pain using the urine dipstick test

    Difference in presence (Yes/No)

    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

  1. 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

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — The nature of the study warrants within-group and between group comparisons. Individual data will not be valuable in a meaningful way as it is an observational case-control study.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Oct 2026 (actual). Primary completion is estimated for Dec 2027, 14 months after the start.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 20, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2026
First posted
Jun 16, 2026
StartActual
Oct 13, 2026was Aug 2026
Primary completionEst.
Dec 20, 2027
CompletionEst.
Jun 2, 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Enrolling by invitation
changed Oct 20, 2026
Start date
Aug 20, 2026→Oct 13, 2026 (actual)
Oct 20, 2026
Contact
No study contact listed any more: removed i•••@leicester.ac.uk · •••8535; removed h•••@leicester.ac.uk
Oct 20, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • University Hospitals of Leicester · Leicester, United KingdomContact removed i•••@leicester.ac.uk · •••8535
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Not yet recruiting→Enrolling by invitation
    Start date Aug 20, 2026→Oct 13, 2026 (now actual)
    Contact No study contact listed any more: removed i•••@leicester.ac.uk · •••8535; removed h•••@leicester.ac.uk
    Site contacts Changed at 1 site. See the sites
    Show the site
    • University Hospitals of Leicester · Leicester, United KingdomContact removed i•••@leicester.ac.uk · •••8535
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07649538
Collaborators
University Hospitals, Leicester
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Oct 13, 2026
Primary completion
Dec 20, 2027 (estimated)
Completion
Jun 2, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Haresh Selvaskandan, MBChB, MRCP, MRes, PhD
principal investigator · University of Leicester, University Hospitals of Leicester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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