LO-PAIgN: Mediators of Loin Pain in Immunoglobulin-A Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in MRI-derived total kidney volume between active pain and follow-up assessments in participants with episodic loin pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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.)
- •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.)
研究组 & 干预措施
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
结局指标
主要结局
Change in MRI-derived total kidney volume between active pain and follow-up assessments in participants with episodic loin pain
时间窗: 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)
Change in MRI-derived renal cortical volume between active pain and follow-up assessments in participants with episodic loin pain
时间窗: 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)
Change in MRI-derived renal medullary volume between active pain and follow-up assessments in participants with episodic loin pain
时间窗: 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)
Change in MRI-derived renal T1 relaxation time between active pain and follow-up assessments in participants with episodic loin pain
时间窗: 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)
Presence of renal pelvis abnormality on renal MRI in participants with episodic loin pain and participants with no history of loin pain
时间窗: 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
Difference in MRI-derived total kidney volume between participants with episodic loin pain and participants with no history of loin pain
时间窗: 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)
Difference in MRI-derived renal cortical volume between participants with episodic loin pain and participants with no history of loin pain
时间窗: 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)
Difference in MRI-derived renal medullary volume between participants with episodic loin pain and participants with no history of loin pain
时间窗: 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)
Difference in MRI-derived renal T1 relaxation time between participants with episodic loin pain and participants with no history of loin pain
时间窗: 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)
Assessment of organ-level changes between pain-prone patients and those with no history of loin pain using structural renal magnetic resonance imaging (MRI)
时间窗: 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
次要结局
- 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(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(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(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.(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(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(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(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(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.)