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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Postgraduate Researcher
- 電話番号：+447539398535
- メール：ik186@leicester.ac.uk
研究連絡先のバックアップ
- 名前：Chief Investigator
- メール：hs328@leicester.ac.uk
研究場所
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Leicester
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Leicester、Leicester、イギリス、LE1 7HA
- University Hospitals of Leicester
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コンタクト：
- Ishika Khan
- 電話番号：07539398535
- メール：ik186@leicester.ac.uk
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
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.
説明
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.)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in MRI-derived total kidney volume between active pain and follow-up assessments in participants with episodic loin pain
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
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
時間枠：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.
|
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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
時間枠：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
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
時間枠：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.
|
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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
時間枠：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)
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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.
時間枠：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
時間枠：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)
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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
時間枠：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.
|
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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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in estimated glomerular filtration rate between participants with episodic loin pain and participants with no history of loin pain
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Haresh Selvaskandan, MBChB, MRCP, MRes, PhD、University of Leicester, University Hospitals of Leicester
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 1104
- 364280 (その他の識別子：Health Research Authority)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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