Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

9. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

40

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in MRI-derived total kidney volume between active pain and follow-up assessments in participants with episodic loin pain
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Difference in estimated glomerular filtration rate between participants with episodic loin pain and participants with no history of loin pain
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Leicester

Mitarbeiter

University Hospitals, Leicester

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. August 2026

Primärer Abschluss (Geschätzt)

20. Dezember 2027

Studienabschluss (Geschätzt)

2. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

2. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1104
  • 364280 (Andere Kennung: Health Research Authority)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur IgA-Nephropathie (IgAN)

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Angola

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren