LUNELORD: A Descriptive, Prospective Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and QoL of Patients With LUpus NEphritis and Long-term ORgan Damage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Number of participants with demographic characteristics
研究概览
简要总结
This is a multicenter prospective study to assess clinical characteristics, demographics, treatment and health-related quality of life (HRQoL) of lupus nephritis (LN) participants across 5 Gulf countries (United Arab Emirates [UAE], Qatar, Bahrain, Kuwait and Oman).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •More than or equal to 18 years of age
- •Clinician diagnosed LN participants.
- •At least one visit to the investigational center during 12 months prior to the baseline visit, recorded in medical documentation.
- •Literacy in English or Arabic allowing to fully comprehend the written informed consent and study-specific patient reported questionnaires.
排除标准
- •Incomplete medical records to be able to assess the disease severity or absence of any of the following renal laboratory results from the medical record within the last twelve months: a. Urinary protein to creatinine ratio (UPCR) or 24-hour proteinuria or urine sediment (activity). b. Serum creatinine or estimated glomerular filtration rate (eGFR); or measured glomerular filtration rate (GFR), if eGFR is not available.
- •Current or medical history of: a. Congenital or acquired immunodeficiency. b. Malignancy in active treatment phase. c. Acute viral infection, such as human immunodeficiency virus (HIV) infection, requiring hospitalization.
研究组 & 干预措施
Participants with Lupus Nephritis
干预措施: Medical chart review (Other)
Participants with Lupus Nephritis
干预措施: Participant completed survey (Other)
结局指标
主要结局
Number of participants with demographic characteristics
时间窗: Up to 1 year
Number of participants with treatments for lupus nephritis
时间窗: Up to 1 year
Number of participants with clinical manifestations of Lupus Nephritis
时间窗: Up to 1 year
36-Item Short Form Health Survey (SF-36) total score
时间窗: Up to 1 year
The SF-36 is a 36-item QoL questionnaire covering 8 health domains. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Number of participants with comorbidities
时间窗: Up to 1 year
Severity of Lupus Nephritis in participants
时间窗: Up to 1 year
次要结局
- Number of participants with renal remission(Up to 1 year)
- Number of participants with refractory Lupus Nephritis(Up to 1 year)
- Direct medical costs associated with lupus nephritis management(Up to 1 year)
- Change from Baseline in anti-nuclear antibody(Baseline and up to 1 year)
- Number of participants with healthcare resource utilization (HCRU)(Up to 1 year)
- Change from Baseline in complement (C3 and C4) levels(Baseline and up to 1 year)
- Change from Baseline in antibody to double-stranded deoxyribonucleic acid test (anti-dsDNA antibody)(Baseline and up to 1 year)
- Changes in the SF-36 physical and mental components score and the total scores at one year (Scores on a scale)(Baseline and 1 year)
- Number of participants with difference in treatment patterns(Up to 1 year)