Recruiting

Lupus Nephritis Pathway

Sponsor:

Duke University

Code:

NCT07783152

Conditions

Lupus Nephritis (LN)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lupus Nephritis (LN) Care Pathway

Study Details

Brief summary:

The purpose of this study is to evaluate an approach to managing patients with lupus nephritis called the Lupus Nephritis (LN) Pathway among approximately 25 patients. Activities include answering surveys and participating in an interview.

Objectives include: 1) Assess feasibility and acceptability of the LN Care Pathway, 2) evaluate user experiences to identify opportunities for improvement, and 3) explore the preliminary effect of this pathway on medication adherence and clinical outcomes.

Conditions

Lupus Nephritis (LN)

Study ID

NCT07783152

Start date

Oct 14, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Active patient at a Duke University Health System clinic
  • Current diagnosis of Systemic Lupus Erythematosus (SLE) based on the 1997 ACR,32 2012 Systemic Lupus International Collaborating Clinics (SLICC),33 or 2019 European League Against Rheumatism (EULAR)/ACR (American College of Rheumatology)34 classification criteria
  • Aged 18 years or older
  • Able to provide informed consent
  • Able to attend telemedicine visits
  • New onset or ongoing active LN based on rheumatologist or nephrologist evaluation

Exclusion Criteria:

  • Patients with severe cognitive impairment
  • Do not wish to receive longitudinal care at our health system

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Lupus Nephritis (LN) Care Pathway

All participants receive the same LN Care Pathway intervention.

Interventions

Lupus Nephritis (LN) Care Pathway

The LN Care Pathway is an innovative, scalable, team-based model that leverages clinical pharmacist practitioners (CPPs) to deliver frequent telemedicine visits and implement protocol-based adherence support, medication management, and remote monitoring, all with oversight from rheumatology and nephrology physicians.

Primary outcome measure

  • Proportion of Eligible Patients Who Consent to and Enroll in the Study [ Time Frame: From study start through completion of enrollment ]
  • Proportion of Enrolled Participants Who Complete the 6-Month Lupus Nephritis Care Pathway [ Time Frame: 6 months ]
  • Proportion of Enrolled Participants Who Complete at Least 50% of Planned Visits [ Time Frame: 6 months ]
  • Feasibility of the Lupus Nephritis Care Pathway as Measured by the Feasibility of Intervention Measure [ Time Frame: 6 months ]
  • Acceptability of the Lupus Nephritis Care Pathway as Measured by the Acceptability of Intervention Measure [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Edna Scarlett

919-684-6150edna.scarlett@duke.edu

Dana Burshell, MPH

dana.burshell@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27708

Principal Investigator:

Kai Sun, MD

More Information

Sponsor

Duke University

Last update posted

Oct 19, 2026

Last verified

Aug, 2026

Keywords

  • lupus nephritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Duke University on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.