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| ID | Type | Description | Link |
|---|---|---|---|
| 364280 | Other Identifier | Health Research Authority |
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| Name | Class |
|---|---|
| University Hospitals, Leicester | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Within the 12 months before or at enrolment |
Inclusion Criteria:
Cohort A
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:
Cohort A
Cohort B
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Postgraduate Researcher | Contact | +447539398535 | ik186@leicester.ac.uk | |
| Chief Investigator | Contact | hs328@leicester.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Haresh Selvaskandan, MBChB, MRCP, MRes, PhD | University of Leicester, University Hospitals of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester | Leicester | Leicester | LE1 7HA | United Kingdom |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2026 | Jun 2, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Cohort B | May 22, 2026 | Jun 2, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Cohort A | May 22, 2026 | Jun 2, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: e-Consent form | May 22, 2026 | Jun 2, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D021501 | Flank Pain |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Blood and urine samples
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. |
| 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 |
| 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) | 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) | 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 | Difference in abundance (count per high magnification field) | Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit |
| 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) | 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 the urine dipstick test | Difference in presence (Yes/No) | Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit |
| 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) | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |