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NCT Number: NCT07649538

Mediators of Loin Pain in IgA Nephropathy

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.

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Key information

Conditions

IgA Nephropathy (IgAN) Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Flank Pain Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cohort A

  • ≥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
  • ≥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

Cohort A

  • 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
  • Therapies that interfere with immune-mediation like steroids and complement inhibitors
  • Kidney transplant recipients
  • Current participation in an interventional study that may affect kidney function
  • Patients on dialysis
  • Patients with implants that are not MRI-safe (pacemakers, implantable defibrillators, cochlear implants, some shunts, neurostimulators, some aneurysm clips, etc.)

Cohort B

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

Treatment and study plan

Primary outcomes

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

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

    Differences in total kidney volume (mL)

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

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

    Differences in renal cortical volume (mL)

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

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

    Differences in renal medullary volume (mL)

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

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

    Difference in renal T1 relaxation time (ms)

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

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

    Presence of renal pelvis abnormality, including renal pelvis dilatation

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

    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.

    Difference in total kidney volume (mL)

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

    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.

    Difference in renal cortical volume (mL)

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

    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.

    Difference in renal medullary volume (mL)

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

    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.

    Difference in T1 relaxation time (ms)

  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)

    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.

    Presence of renal pelvis abnormality, including renal pelvis dilatation

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

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

    Differences in abundance ratios

  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

    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.

    Differences in abundance ratios

  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

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

    Differences in concentrations (w/v)

  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.

    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.

    Differences in concentrations (w/v)

  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

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

    Difference in abundance (count per high magnification field)

  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

    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.

    Difference in abundance (count per high magnification field)

  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

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

    Difference in presence (Yes/No)

  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

    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.

    Difference in presence (Yes/No)

Other outcomes

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

    Time frame: Within the 12 months before or at enrolment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Investigator

CONTACT

[email protected]

Postgraduate Researcher

CONTACT

[email protected]

+447539398535

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • University Hospitals, Leicester

Registry information

Official study title

LO-PAIgN: Mediators of Loin Pain in Immunoglobulin-A Nephropathy

Acronym: LO-PAIgN

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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