Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

9 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

40

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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.)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in MRI-derived total kidney volume between active pain and follow-up assessments in participants with episodic loin pain
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Difference in estimated glomerular filtration rate between participants with episodic loin pain and participants with no history of loin pain
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Leicester

Współpracownicy

University Hospitals, Leicester

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

20 sierpnia 2026

Zakończenie podstawowe (Szacowany)

20 grudnia 2027

Ukończenie studiów (Szacowany)

2 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

2 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

16 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1104
  • 364280 (Inny identyfikator: Health Research Authority)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Nefropatia IgA (IgAN)

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Malawi

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj