Mediators of Loin Pain in IgA Nephropathy (LO-PAIgN)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Postgraduate Researcher
- 전화번호: +447539398535
- 이메일: ik186@leicester.ac.uk
연구 연락처 백업
- 이름: Chief Investigator
- 이메일: hs328@leicester.ac.uk
연구 장소
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Leicester
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Leicester, Leicester, 영국, LE1 7HA
- University Hospitals of Leicester
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연락하다:
- Ishika Khan
- 전화번호: 07539398535
- 이메일: ik186@leicester.ac.uk
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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.
설명
Inclusion Criteria:
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
Exclusion Criteria:
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
- 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.)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Cohort A: Loin pain group
This group would consist of patients with IgAN who experience loin pain episodes
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Cohort B: No loin pain group
This group would consist of patients with IgAN who have never experienced loin pain
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in MRI-derived total kidney volume between active pain and follow-up assessments in participants with episodic loin pain
기간: Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.
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Differences in total kidney volume (mL)
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Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.
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Change in MRI-derived renal cortical volume between active pain and follow-up assessments in participants with episodic loin pain
기간: Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.
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Differences in renal cortical volume (mL)
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Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.
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Change in MRI-derived renal medullary volume between active pain and follow-up assessments in participants with episodic loin pain
기간: Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.
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Differences in renal medullary volume (mL)
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Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.
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Change in MRI-derived renal T1 relaxation time between active pain and follow-up assessments in participants with episodic loin pain
기간: Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.
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Difference in renal T1 relaxation time (ms)
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Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.
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Presence of renal pelvis abnormality on renal MRI in participants with episodic loin pain and participants with no history of loin pain
기간: Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.
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Presence of renal pelvis abnormality, including renal pelvis dilatation
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Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit.
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Difference in MRI-derived total kidney volume between participants with episodic loin pain and participants with no history of loin pain
기간: 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.
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Difference in total kidney volume (mL)
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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.
|
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Difference in MRI-derived renal cortical volume between participants with episodic loin pain and participants with no history of loin pain
기간: 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)
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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.
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Difference in MRI-derived renal medullary volume between participants with episodic loin pain and participants with no history of loin pain
기간: 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)
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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
기간: 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.
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Difference in T1 relaxation time (ms)
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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.
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Assessment of organ-level changes between pain-prone patients and those with no history of loin pain using structural renal magnetic resonance imaging (MRI)
기간: 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.
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Presence of renal pelvis abnormality, including renal pelvis dilatation
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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.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit
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Differences in abundance ratios
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Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit
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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
기간: 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.
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Differences in abundance ratios
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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.
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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
기간: Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit
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Differences in concentrations (w/v)
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Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit
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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.
기간: 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.
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Differences in concentrations (w/v)
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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.
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Comparing the presence of urinary factors that indicate active intra-renal injury between an active pain episode and when it subsides using urine microscopy
기간: Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit
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Difference in abundance (count per high magnification field)
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Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit
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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
기간: 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.
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Difference in abundance (count per high magnification field)
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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.
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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
기간: Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit
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Difference in presence (Yes/No)
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Within 72 hours of active loin pain onset and at follow-up assessment at least 2 weeks after the first visit
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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
기간: 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.
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Difference in presence (Yes/No)
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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.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in estimated glomerular filtration rate between participants with episodic loin pain and participants with no history of loin pain
기간: Within the 12 months before or at enrolment
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Difference in estimated glomerular filtration rate (mL/min/1.73
m²)
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Within the 12 months before or at enrolment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Haresh Selvaskandan, MBChB, MRCP, MRes, PhD, University of Leicester, University Hospitals of Leicester
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1104
- 364280 (기타 식별자: Health Research Authority)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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