Lupus Nephritis (LN)NCT07783152
Lupus Nephritis Care Pathway
A study testing Lupus Nephritis (LN) Care Pathway in people with Lupus Nephritis (LN), run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis (LN)
- What is being tested?
- Lupus Nephritis (LN) Care Pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2026to Dec 2028
- Phase
- Interventional
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
Who may be able to join
- 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
Who cannot join
- Patients with severe cognitive impairment
- Do not wish to receive longitudinal care at our health system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dana Burshell, MPH contact
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27708
Kai Sun, MD
Dana Burshell, MPH
About this study
Official title: Evaluation of a Lupus Nephritis Care Pathway Integrating Telemedicine and Clinical Pharmacist Practitioners
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.
Read the detailed description
The Lupus Nephritis (LN) 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.
The investigators will include 25 patients with lupus nephritis. The study primarily assesses the LN Care Pathway's feasibility and acceptability using surveys, exit interviews, and metrics of enrollment, retention, and engagement. The investigators will also evaluate user experiences and identify areas for improvement in exit interviews. Lastly, the investigators will explore preliminary effects on medication adherence and key clinical outcomes
- Conditions
- Lupus Nephritis (LN)
- Being tested
- Lupus Nephritis (LN) Care Pathway
- Keywords
- lupus nephritis
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lupus Nephritis (LN) Care PathwayBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lupus Nephritis (LN) Care Pathway | Experimental | All participants receive the same LN Care Pathway intervention. Receives: Behavioral: Lupus Nephritis (LN) Care Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eligible Patients Who Consent to and Enroll in the Study
The proportion of eligible patients who provide informed consent and enroll in the study. Feasibility of recruitment will be supported if at least 70% of eligible patients consent to and enroll.
Measured: From study start through completion of enrollment
Proportion of Enrolled Participants Who Complete the 6-Month Lupus Nephritis Care Pathway
The proportion of enrolled participants who complete the 6-month Lupus Nephritis Care Pathway. Feasibility of retention will be supported if at least 80% of enrolled participants complete the Care Pathway.
Measured: 6 months
Proportion of Enrolled Participants Who Complete at Least 50% of Planned Visits
The proportion of enrolled participants who complete at least 50% of planned telehealth visits during the 6-month Lupus Nephritis Care Pathway. Feasibility of participant engagement will be supported if at least 75% meet this threshold.
Measured: 6 months
Feasibility of the Lupus Nephritis Care Pathway as Measured by the Feasibility of Intervention Measure
The Feasibility of Intervention Measure is a 4-item measure of perceived feasibility. Each item is rated on a 5-point scale from 1 to 5, with higher scores indicating greater feasibility. The mean score across items will be calculated.
Measured: 6 months
Acceptability of the Lupus Nephritis Care Pathway as Measured by the Acceptability of Intervention Measure
The Acceptability of Intervention Measure is a 4-item measure of perceived acceptability. Each item is rated on a 5-point scale from 1 to 5, with higher scores indicating greater acceptability. The mean score across items will be calculated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start14 Oct 2026
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Nephritis (LN)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Responsible party
- Sponsor
- Investigators
- Kai Sun, MD, MS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783152
- Sponsor's protocol ID
- Pro00120423
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No