Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis

Launched by GLAXOSMITHKLINE · Jul 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying lupus nephritis, a condition that affects the kidneys in people with systemic lupus erythematosus, an autoimmune disease. The research aims to gather information about the characteristics of patients with lupus nephritis, their treatments, and how their health impacts their quality of life. The study is taking place in five Gulf countries: the United Arab Emirates, Qatar, Bahrain, Kuwait, and Oman, and is currently recruiting participants.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with lupus nephritis by a healthcare provider. They should have visited a medical center within the last year and be able to read and understand English or Arabic to complete necessary forms. Participants can expect to share their medical history and complete questionnaires about their health and well-being. This study is important because it will help researchers understand lupus nephritis better and improve care for those affected by it.

Gender

ALL

Eligibility 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.