Last updated: 10/09/2024 06:30:09

A study to evaluate Health-related quality of life in participants with lupus nephritis

GSK study ID
212981
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: The Health-related Quality of Life, Fatigue and Health Utility of Patients with Lupus Nephritis
Trial description: This is a non-interventional, multicenter, prospective cross-sectional survey study with a retrospective chart review component, and a sub-study including a
Sub-group of participants in the United States (US) undergoing a face-to-face qualitative interview (or by telephone if needed). The purpose of this non-interventional study is to characterize the participant’s perspective of Lupus nephritis (LN), including its impact on health-related quality of life (HRQoL), fatigue, and health utility in the US and Germany. The participant’s overall treatment and disease experience will also be explored. The content validity of selected patient report outcomes (PROs) in an LN population will be explored in a subset of US participants.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Short Form-36 (SF-36) score

Timeframe: Up to 10 minutes

Secondary outcomes:

LupusQoL score

Timeframe: Up to 10 minutes

FACIT-Fatigue score

Timeframe: Up to 10 minutes

Patient Global Assessment (PtGA) score

Timeframe: Up to 1 minute

Work Productivity and Activity Impairment (WPAI)-Lupus score

Timeframe: Up to 5 minutes

Euro Quality-5 dimension-3 level (EQ-5D-3L) score

Timeframe: Up to 10 minutes

Number of participants assessed for content validity of selected PROs

Timeframe: Up to 90 minutes

Interventions:
Other: Participant Survey
Other: Qualitative interviews
Enrollment:
44
Observational study model:
Cohort
Primary completion date:
2021-23-11
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Lupus Nephritis
Product
belimumab
Collaborators
Evidera
Study date(s)
December 2020 to January 2022
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Biopsy-proven diagnosis of LN class III, IV or VI (with or without class V) or pure class V.
  • Males or females of age 18 years or older.
  • Absence of any of the following from the medical record within the last six months: renal laboratory results (urinary protein to creatinine ratio [UPCR] or 24-hour proteinuria or urine sediment [activity], serum creatinine or estimated glomerular filtration rate [eGFR] or GFR, if eGFR is not available).
  • Current enrolment in an interventional clinical trial.
Inclusion and exclusion criteria
Inclusion criteria:
  • Biopsy-proven diagnosis of LN class III, IV or VI (with or without class V) or pure class V.
  • Males or females of age 18 years or older.
  • Ability to understand the requirements of the study, provide informed consent (including consent for the use and disclosure of research-related health information), ability to use a computer or hand-held device with internet access, to speak and read English or German and to complete a one-time electronic survey.
  • Consent to medical record access.
Exclusion criteria:
  • Absence of any of the following from the medical record within the last six months: renal laboratory results (urinary protein to creatinine ratio [UPCR] or 24-hour proteinuria or urine sediment [activity], serum creatinine or estimated glomerular filtration rate [eGFR] or GFR, if eGFR is not available).
  • Current enrolment in an interventional clinical trial.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
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Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27517
Status
Study Complete
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Location
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40225
Status
Study Complete
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Location
GSK Investigational Site
Graz, Austria, 8036
Status
Study Complete
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Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
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Location
GSK Investigational Site
Manhasset, New York, United States, 11030
Status
Study Complete
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Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
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Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
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Location
GSK Investigational Site
Kirchheim unter Teck, Baden-Wuerttemberg, Germany, 73230
Status
Study Complete
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Location
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 4A6
Status
Study Complete
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Location
GSK Investigational Site
Katy, Texas, United States, 77494
Status
Study Complete
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Study documents

Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2021-23-11
Actual study completion date
2022-05-01

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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