Mediators of Loin Pain in IgA Nephropathy

NCT07649538 | Not Yet Recruiting

• 2 other identifiers: 1104364280
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IgA Nephropathy (IgAN)

Keywords

Kidney pain; IgAN; IgA nephropathy; Flank pain; Loin pain; Renal pain

Outcome Measures

Primary Outcomes (10)

• 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)

  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)

  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)

  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)

  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 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

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

• 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)

  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 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)

  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 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)

  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 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)

  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.

• 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

  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 (8)

• 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

  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

  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

  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.

  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.

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

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

Other Outcomes (1)

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

  Within the 12 months before or at enrolment

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

University Hospitals of Leicester

Leicester, Leicester, LE1 7HA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples

MeSH Terms

Conditions

Glomerulonephritis, IGA; Flank Pain

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Haresh Selvaskandan, MBChB, MRCP, MRes, PhD

  University of Leicester, University Hospitals of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Postgraduate Researcher

CONTACT

+447539398535; ik186@leicester.ac.uk

Chief Investigator

CONTACT

hs328@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): June 2, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)