Clinical Outcomes Association and Extended Panel Urinary Lymphocyte Subset among Treatment-Naive Patients Diagnosed with Proliferative Lupus Nephritis: A Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Characterise the inflammatory cell lymphocyte subset
研究概览
简要总结
Prospective observational EPULS study at Kasturba Medical College and Hospital, Manipal, using standardized midstream urine collection processed within 30 minutes and a dual platform workflow to quantify an 11-color, 12-marker lymphocyte panel by flow cytometry at baseline, 3, 6, and 12 months in lupus nephritis to derive urine immune cell signatures that associate with renal histology (class and scores) and predict clinical remission as a noninvasive, serially trackable biomarker for monitoring. Urine processing follows automated microscopy to guide volume and concentration and acquisition on a flow cytometer under SOP based QC. The 36 month interdepartmental Nephrology and Pathology study embeds monthly induction and three monthly maintenance follow up under standard of care, targeting 30 lupus nephritis participants and 15 disease controls to enable consistent EPULS profiling across visits.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 8.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •30 newly diagnosed LN patients with renal biopsy-proven Class II, IV, or combination class with Class V lesions on renal histology, willing to provide informed consent to participate in the study.
- •15 newly diagnosed SLE patients without renal involvement as Disease Controls (DC).
- •Absence of renal involvement is defined as, i.
- •Urine RBCs: lesser than 2/ HPF ii.
- •Random UpCr: lesser than 0.3mg/mg or 24hr-urine protein lesser than 300mg/ day iii.
- •Serum creatinine: lesser than 1.l mg/dL SLE patients on a corticosteroid dose equivalent or less than 0.2mg/kg/day of prednisolone in the last one month.
- •Patients previously treated with immunosuppressants such as mycophenolate mofetil (MMF) or cyclophosphamide may be included only if a minimum of: 3 months have passed since the last dose of MME, and 12 months since the last dose of cyclophosphamide, and the patient demonstrates clinical stability with no recent flare, to ensure immune reconstitution and minimise confounding of urinary immune cell profiles.
排除标准
- •Current/ recent infection in the last two weeks before enrolment.
- •Active Malignancy, blood dyscrasias, or current use of chemotherapeutic medications.
结局指标
主要结局
Characterise the inflammatory cell lymphocyte subset
时间窗: 36 months
distribution in the urine by flow cytometry.
时间窗: 36 months
次要结局
- Changes in the Extended Panel Urinary Lymphocyte Subsets (EPULS) from the time of recruitment (with high disease activity) and at each follow-up interval (0 months, 3 months, 6 months, and 12 months).(Change in the EPULS profile over time with the class of immunosuppressive drug used for the management of LN.)
研究者
Dharshan Rangaswamy
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal.