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Mediators of Loin Pain in IgA Nephropathy (LO-PAIgN)

9. června 2026 aktualizováno: University of Leicester

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

40

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

Inclusion Criteria:

Cohort A

  1. ≥18 years of age at the time of recruitment
  2. IgAN diagnosis confirmed with a renal biopsy
  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:

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 steroids 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.)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in MRI-derived total kidney volume between active pain and follow-up assessments in participants with episodic loin pain
Časové okno: 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)
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
Časové okno: 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)
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
Časové okno: 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)
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
Časové okno: 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)
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
Časové okno: 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
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
Časové okno: 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)
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
Časové okno: 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)
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
Časové okno: 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)
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
Časové okno: 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)
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)
Časové okno: 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
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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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
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
Časové okno: 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
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
Časové okno: 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)
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.
Časové okno: 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)
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
Časové okno: 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)
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
Časové okno: 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)
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
Časové okno: 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)
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
Časové okno: 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)
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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Difference in estimated glomerular filtration rate between participants with episodic loin pain and participants with no history of loin pain
Časové okno: Within the 12 months before or at enrolment
Difference in estimated glomerular filtration rate (mL/min/1.73 m²)
Within the 12 months before or at enrolment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Leicester

Spolupracovníci

University Hospitals, Leicester

Vyšetřovatelé

  • Vrchní vyšetřovatel: Haresh Selvaskandan, MBChB, MRCP, MRes, PhD, University of Leicester, University Hospitals of Leicester

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

20. srpna 2026

Primární dokončení (Odhadovaný)

20. prosince 2027

Dokončení studie (Odhadovaný)

2. června 2028

Termíny zápisu do studia

První předloženo

2. června 2026

První předloženo, které splnilo kritéria kontroly kvality

9. června 2026

První zveřejněno (Aktuální)

16. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1104
  • 364280 (Jiný identifikátor: Health Research Authority)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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