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

An observational study of Systemic Lupus Erythematosus, run by GlaxoSmithKline at 6 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: Participant completed survey and Medical chart review
How many people: 193 participants
Where: 6 sitesin 4 countries
Study dates: 14 Sep 2021to 31 Oct 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

6 sites in 4 countries.

Country

City, postcode or hospital

6 sites in 4 countries

United Arab Emirates3 sites

GSK Investigational Site
Abu Dhabi
GSK Investigational Site
Al Ain City
GSK Investigational Site
Dubai

Other trials in United Arab Emirates

Kuwait1 site

GSK Investigational Site
Shweikh

Other trials in Kuwait

Oman1 site

GSK Investigational Site
Bawshar

Other trials in Oman

Qatar1 site

GSK Investigational Site
Alrayyan

Other trials in Qatar

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.

Study groups in NCT04971590
Study group	Role	What they receive
Participants with Lupus Nephritis		Not described Receives: Other: Participant completed survey; Other: Medical chart review

What is being measured

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

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)
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
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
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
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)
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)

Secondary outcomes (7)

Number of Participants With Refractory Lupus Nephritis
Refractory systemic lupus nephritis was defined as inefficacy of cyclophosphamide, use of rituximab, splenectomy, or inefficacy of >=2 immunosuppressives (methotrexate, leflunomide, abatacept, anti-tumor necrosis factor [anti-TNF], azathioprine, mycophenolate mofetil, and/or mycophenolic acid).
Measured: Up to 12 months
Number of Participants With Abnormal Findings for Serological Markers
Number of participants with abnormal findings for serological markers (including anti-nuclear antibody, anti-double-stranded deoxyribonucleic acid [dsDNA] antibody and complement levels [C3, C4]) has been presented. Abnormal values were determined by the investigator.
Measured: At 3, 6, 9 and 12 months
Number of Participants With Renal Remission That Were Associated With Clinical Factors, Biomarkers, and Treatments
Renal remission was defined as proteinuria of <0.7 grams per day (g/d) or <0.5g/d or at physicians' discretion. Number of participants with renal remission that were associated with clinical factors, biomarkers, and treatments has been presented.
Measured: Up to 12 months
Percent Change From Baseline in SF-36 Scores for Each Health Domain:Physical Functioning, Pain, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problem, Emotional Well-being, Social Functioning, Energy/Fatigue and General Health
The 36-Item Short Form Health Survey (SF-36) is a 36-item 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. Baseline was considered as Day 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value (at 12 months). Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100. Percent change from Baseline values of individual domain scores have been presented.
Measured: Baseline (Day 1) and at 12 months
Number of Participants With Hospitalizations and Intensive Care Unit (ICU) Hospitalizations
Number of participants with hospitalizations and ICU hospitalizations has been presented.
Measured: Up to 12 months
Direct Medical Costs Associated With Lupus Nephritis Management
The direct medical costs of hospitalization and ICU hospitalization per participant associated with lupus nephritis management in United States dollars (USD) of United Arab Emirates (UAE), Kuwait, Qatar, and Oman were analyzed. Costs are described in local currency of each country and converted in USD dollars using the average exchange rate for each local currency versus USD in 2023. Direct medical costs associated with lupus nephritis management have been reported as USD.
Measured: Up to 12 months
Number of Participants With Treatment for Lupus Nephritis by Sector (Public or Private Sector)
Number of participants with treatments for lupus nephritis (Prednisone, Chloroquine, Hydroxychloroquine, Azathioprine, Belimumab, Tacrolimus, Cyclosporine A, Voclosporin, Cyclophosphamide, Mycophenolate mofetil, Methotrexate, Rituximab) among physicians in the public and private sectors, respectively has been presented. Data has been presented per treatment received either in public sector or private sector up to 12 months. Participants may have received more than 1 treatment.
Measured: Up to 12 months

Timeline

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

14 Sep 202131 Oct 2024

First posted21 Jul 2021
Study start14 Sep 2021
Primary completion31 Oct 2024
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.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 193 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04971590
Sponsor's protocol ID: 216989
Status last verified: Jan 2026
First submitted: 12 Jul 2021
Last updated: 22 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04971590
Acronym / sponsor ID: 216989
Conditions: Systemic Lupus Erythematosus
Keywords: LUNELORD, Systemic lupus erythematosus, Lupus nephritis, Organ damage, Gulf countries, Real-world
Study type: Observational
Recruitment status: Completed
Enrolment: 193 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 Sep 2021 (actual)
Primary completion: 31 Oct 2024 (actual)
Study completion: 31 Oct 2024 (actual)
First posted: 21 Jul 2021 (actual)
Results: Posted 22 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Participants with Lupus Nephritis	–	Other: Participant completed survey, Other: Medical chart review

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: 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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Participant completed surveyParticipants will be required to complete the participant survey.	Other	Participants with Lupus Nephritis
Medical chart reviewData will be collected from medical charts of participants.	Other	Participants with Lupus Nephritis

Primary outcome

Number of Participants Categorized by Demographic Characteristics
Time frame: At Baseline (Day 1)
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.
Number of Participants With Active Clinical Manifestations of Lupus Nephritis
Time frame: Up to 12 months
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.
Number of Participants With Comorbidities
Time frame: Up to 12 months
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.
Number of Participants With Severe Lupus Nephritis
Time frame: Up to 12 months
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.
Number of Participants Categorized by Treatments for Lupus Nephritis
Time frame: At Baseline (Day 1)
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.
Short Form Health Survey (SF-36) Health-related Quality of Life Domain Score
Time frame: At Baseline (Day 1)
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.

7 secondary outcomes

Number of Participants With Refractory Lupus Nephritis
Time frame: Up to 12 months
Number of Participants With Abnormal Findings for Serological Markers
Time frame: At 3, 6, 9 and 12 months
Number of Participants With Renal Remission That Were Associated With Clinical Factors, Biomarkers, and Treatments
Time frame: Up to 12 months
Percent Change From Baseline in SF-36 Scores for Each Health Domain:Physical Functioning, Pain, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problem, Emotional Well-being, Social Functioning, Energy/Fatigue and General Health
Time frame: Baseline (Day 1) and at 12 months
Number of Participants With Hospitalizations and Intensive Care Unit (ICU) Hospitalizations
Time frame: Up to 12 months
Direct Medical Costs Associated With Lupus Nephritis Management
Time frame: Up to 12 months
Number of Participants With Treatment for Lupus Nephritis by Sector (Public or Private Sector)
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 22 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Lupus Nephritis	193	193

Primary outcome: Number of Participants Categorized by Demographic Characteristics

Time frame: At Baseline (Day 1). Count of participants. Unit: Participants

Measure	Participants With Lupus Nephritis n = 193
Health insurance coverage, yes	143
Health insurance coverage, no	50
Employment status, full time	88
Employment status, part-time	3
Employment status, housewife	30
Employment status, not working	58
Employment status, other	9
Employment status, retired	4

Population analysed: "All Subjects Enrolled (ASE) Population" included all participants who met the inclusion and exclusion criteria.

Primary outcome: Number of Participants With Active Clinical Manifestations of Lupus Nephritis

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	Participants With Lupus Nephritis n = 193
Pedal edema	59
Serositis	23
Hair loss	46
Decreased urine output	13
Malar rash	32
Discoid rash	17
Photosensitive rash	25
Joint pain/arthritis	94

Population analysed: ASE Population. Only those participants who were analyzed (i.e., contributed to data reported in the table) for this outcome measure were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified category.

Primary outcome: Number of Participants With Comorbidities

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	Participants With Lupus Nephritis n = 193
Value	134

Population analysed: "ASE Population" included all participants who met the inclusion and exclusion criteria.

Primary outcome: Number of Participants With Severe Lupus Nephritis

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	Participants With Lupus Nephritis n = 190
Value	60

Population analysed: ASE Population. Only those participants who were analyzed (i.e., contributed to data reported in the table) for this outcome measure were included in the 'Overall Number of Participants Analyzed' field. Participants with at least one SLEDAI-2K score assessment were included in this analysis.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality and serious adverse events were collected up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Lupus Nephritis	5 of 193 (2.6%)	0 of 0	1 of 193

Limitations and caveats (from the sponsor): Healthcare Resource Utilization and costs: 1. Relevant data was collected in local currency, as United States Dollar and local currency were used based on a fixed annual rate. 2. In order to map the costs at Government hospitals, these hospitals were asked to list the costs of their services and to describe consultation fees of their salaried healthcare practitioners. 3. Assumptions were made on out-of-pocket expenses that were not recorded.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Systemic Lupus Erythematosus

Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

6 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Systemic Lupus Erythematosus, run by GlaxoSmithKline at 6 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Arab Emirates, Kuwait, Oman, Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Categorized by Demographic Characteristics (time frame: At Baseline (Day 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04971590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.