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

9 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

40

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Regno Unito
    • Leicester
      • Leicester, Leicester, Regno Unito, LE1 7HA
        • University Hospitals of Leicester
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in MRI-derived total kidney volume between active pain and follow-up assessments in participants with episodic loin pain
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in estimated glomerular filtration rate between participants with episodic loin pain and participants with no history of loin pain
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Leicester

Collaboratori

University Hospitals, Leicester

Investigatori

  • Investigatore principale: Haresh Selvaskandan, MBChB, MRCP, MRes, PhD, University of Leicester, University Hospitals of Leicester

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 agosto 2026

Completamento primario (Stimato)

20 dicembre 2027

Completamento dello studio (Stimato)

2 giugno 2028

Date di iscrizione allo studio

Primo inviato

2 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1104
  • 364280 (Altro identificatore: Health Research Authority)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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