IgA Nephropathy (IgAN)LO-PAIgNNCT07649538
Mediators of Loin Pain in IgA Nephropathy
An observational study of IgA Nephropathy (IgAN), run by University of Leicester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN)
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2026to 2 Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- 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
Who cannot join
- 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
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- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University Hospitals of Leicester
Leicester, Leicester, LE1 7HA
About this study
Official title: LO-PAIgN: Mediators of Loin Pain in Immunoglobulin-A 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.
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.
- Conditions
- IgA Nephropathy (IgAN)
- Keywords
- Kidney pain, IgAN, IgA nephropathy, Flank pain, Loin pain, Renal pain
- Medical subject headings
- Glomerulonephritis, IGA, Flank Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Differences in abundance ratios
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start13 Oct 2026
- Primary completion20 Dec 2027 (estimated)
- Study completion2 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Haresh Selvaskandan, MBChB, MRCP, MRes, PhD, Principal investigator, University of Leicester, University Hospitals of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649538
- Sponsor's protocol ID
- 1104
- Other IDs
- 364280
- Acronym
- LO-PAIgN
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.