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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Participants with lupus nephritis as defined by physician per participants hospital records prior to the enrolment visit or at diagnosis.

Trial locations and contacts

6 sites in 4 countries.

About this study

Official title: LUNELORD: A Descriptive, Prospective Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and QoL of Patients With LUpus NEphritis and Long-term ORgan Damage

Conditions

Systemic Lupus Erythematosus

Being tested

Participant completed survey, Medical chart review

Keywords

LUNELORD, Systemic lupus erythematosus, Lupus nephritis, Organ damage, Gulf countries, Real-world

Medical subject headings

Lupus Erythematosus, Systemic, Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Participant completed surveyOther

  Participants will be required to complete the participant survey.

• Medical chart reviewOther

  Data will be collected from medical charts of participants.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of Participants Categorized by Demographic Characteristics

   Number of participants categorized by demographic characteristics including - health insurance coverage (yes, no), employment status (full time, part-time, housewife, not working, other, retired, self-employment), cigarette smoking status (current smoker, ex-smoker, non-smoker, unknown) and alcohol consumption (current, former, never, unknown) has been presented.

   Measured: At Baseline (Day 1)

2. Number of Participants With Active Clinical Manifestations of Lupus Nephritis

   The active clinical manifestations included pedal edema, serositis, hair loss, decreased urine output, malar rash, discoid rash, photosensitive rash, joint pain/arthritis, hypertension, oral ulcer, seizure, psychosis, proteinuria, microscopic hematuria, anemia, thrombocytopenia, renal failure, leukopenia, other (autoimmune hepatitis, raised Serum creatinine with estimated glomerular filtration rate [eGFR] 59 milliliters per minute [ml/min]/1.73 meter square [m^2]). Participants may have more than 1 active clinical manifestations of Lupus Nephritis.

   Measured: Up to 12 months

3. Number of Participants With Comorbidities

   Participants with comorbidities (such as antiphospholipid syndrome/thrombotic microangiopathy, obesity, cardiovascular disease, diabetes) observed since the date of first diagnosis of lupus nephritis has been presented.

   Measured: Up to 12 months

4. Number of Participants With Severe Lupus Nephritis

   Severe lupus nephritis was defined as participants with Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score greater than or equal to (>=) 10. SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity.

   Measured: Up to 12 months

5. Number of Participants Categorized by Treatments for Lupus Nephritis

   Number of participants categorized by treatments for lupus nephritis including prednisone, chloroquine, hydroxychloroquine, azathioprine, belimumab, tacrolimus, cyclosporine, voclosporin, cyclophosphamide, mycophenolate mofetil, methotrexate, and rituximab has been presented. Participants may have received more than 1 treatment for lupus nephritis.

   Measured: At Baseline (Day 1)

6. Short Form Health Survey (SF-36) Health-related Quality of Life Domain Score

   The 36-Item Short Form Health Survey (SF-36) is a 36-item Health-Related Quality of Life (HRQoL) questionnaire covering 8 health domains: physical functioning, Pain, Role limitations due to physical health, Role limitations due to emotional problems, emotional well-being, Social Functioning, energy/fatigue, and General Health. The individual question items are first summed for each item under the various sections. Then, those domain scores were weighted to a scale ranging between 0 to 100, where higher score represents better health. Individual domain scores have been presented.

   Measured: At Baseline (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted21 Jul 2021
2. Study start14 Sep 2021
3. Primary completion31 Oct 2024
4. Study completion31 Oct 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
• More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.