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Recruiting OBSERVATIONAL NCT05934149

Lupus Landmark Study: A Prospective Registry and Biorepository

Lupus Nexus Landmark Study: A Prospective Registry and Biorepository

Sponsor: Lupus Research Alliance

Updated 12 times since 2023 Last updated: Apr 10, 2026 Started: Jun 28, 2023 Primary completion: Dec 1, 2035 Completion: Dec 1, 2035
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05934149, this observational or N/A phase trial focuses on Lupus Nephritis and Neuropsychiatric Systemic Lupus Erythematosus and remains actively recruiting participants. Sponsored by Lupus Research Alliance, it has been updated 12 times since 2023, reflecting substantial change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Study Description(click to expand)

This is a multicenter registry and biorepository conducted in the United States (US) and Canada. The registry will enroll over 3500 individuals with SLE over the course of five years into one of following four cohorts: * New Onset: individuals with a new diagnosis of SLE * Active Lupus Nephritis: individuals with a recent diagnosis of LN * Extra-Renal Lupus Flare: individuals who have experienced a recent flare * Prevalent Cases: individuals with lupus who do not meet the criteria for one of the other cohorts The registry data will include but is not limited to: patient demographics, medical history, clinician-reported outcomes (ClinROs), patient-reported outcomes (PROs), social history and determinants of health, and environmental exposures. Participants will also be asked to allow access to their medical records. Biological samples, including whole blood, urine, saliva, stool and tissue will be collected throughout the study. These biospecimens will be used for a broad range of analyses, including genetics, genomics, proteomics, biomarker discovery and microbiome profiling.

This is a multicenter registry and biorepository conducted in the United States (US) and Canada. The registry will enroll over 3500 individuals with SLE over the course of five years into one of following four cohorts:

* New Onset: individuals with a new diagnosis of SLE * Active Lupus Nephritis: individuals with a recent diagnosis of LN * Extra-Renal Lupus Flare: individuals who have experienced a recent flare * Prevalent Cases: individuals with lupus who do not meet the criteria for one of the other cohorts

The registry data will include but is not limited to: patient demographics, medical history, clinician-reported outcomes (ClinROs), patient-reported outcomes (PROs), social history and determinants of health, and environmental exposures. Participants will also be asked to allow access to their medical records.

Biological samples, including whole blood, urine, saliva, stool and tissue will be collected throughout the study. These biospecimens will be used for a broad range of analyses, including genetics, genomics, proteomics, biomarker discovery and microbiome profiling.

Status Flow

~Aug 2023 – ~Nov 2023 · 3 months · monthly snapshotRecruiting~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotRecruiting~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Mar 2025 · 5 months · monthly snapshotRecruiting~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshotRecruiting~Sep 2025 – ~Apr 2026 · 7 months · monthly snapshotRecruitingApr 16, 2026 – present · 5 months · daily APIRecruiting

Change History

12 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Recruiting

  2. Sep 2025 — Apr 2026 [monthly]

    Recruiting

  3. Apr 2025 — Sep 2025 [monthly]

    Recruiting

  4. Mar 2025 — Apr 2025 [monthly]

    Recruiting

  5. Oct 2024 — Mar 2025 [monthly]

    Recruiting

Show 7 earlier versions
  1. Sep 2024 — Oct 2024 [monthly]

    Recruiting

  2. Aug 2024 — Sep 2024 [monthly]

    Recruiting

  3. Jul 2024 — Aug 2024 [monthly]

    Recruiting

  4. Jan 2024 — Jul 2024 [monthly]

    Recruiting

  5. Dec 2023 — Jan 2024 [monthly]

    Recruiting

  6. Nov 2023 — Dec 2023 [monthly]

    Recruiting

  7. Aug 2023 — Nov 2023 [monthly]

    Recruiting

    First recorded

Jun 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).

Contact Information

Sponsor contact:
  • Lupus Research Alliance
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .