Assessing the characteristics and quality of life in lupus nephritis patients
LUNELORD: A Descriptive, Prospective Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and QoL of Patients With LUpus NEphritis and Long-term ORgan Damage
This study looks at the health and quality of life of people with lupus nephritis in five Gulf countries to better understand their experiences and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Locations | 1 site (Dubai) |
| Trial ID | NCT04971590 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to evaluate the clinical features, demographics, treatment regimens, and health-related quality of life of participants diagnosed with lupus nephritis across five Gulf countries, including the UAE, Qatar, Bahrain, Kuwait, and Oman. Participants will complete surveys and have their medical charts reviewed to gather comprehensive data. The study seeks to enhance understanding of lupus nephritis and its impact on patients in this region.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been clinically diagnosed with lupus nephritis and can provide informed consent in English or Arabic.
Not a fit: Patients with incomplete medical records or those with certain medical histories, such as active malignancies or immunodeficiencies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that improve the management and treatment of lupus nephritis, ultimately enhancing patient quality of life.
How similar studies have performed: While similar studies have been conducted, this specific approach focusing on the Gulf region and the comprehensive assessment of quality of life in lupus nephritis patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Dubai
- GSK Investigational Site — Dubai, United Arab Emirates (Recruiting)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.