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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Lupus Nephritis Care Pathway Integrating Telemedicine and Clinical Pharmacist Practitioners
- ClinicalTrials.gov ID
- NCT07783152
- Acronym / sponsor ID
- Pro00120423
- Conditions
- Lupus Nephritis (LN)
- Keywords
- lupus nephritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Study start
- 14 Oct 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lupus Nephritis (LN) Care Pathway | Experimental | Behavioral: Lupus Nephritis (LN) Care PathwayAll participants receive the same LN Care Pathway intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with severe cognitive impairment
- Do not wish to receive longitudinal care at our health system
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 |
|---|---|---|
| Lupus Nephritis (LN) Care PathwayThe 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. | Behavioural | Lupus Nephritis (LN) Care Pathway |
Primary outcome
Proportion of Eligible Patients Who Consent to and Enroll in the Study
Time frame: From study start through completion of enrollment
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.
Proportion of Enrolled Participants Who Complete the 6-Month Lupus Nephritis Care Pathway
Time frame: 6 months
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.
Proportion of Enrolled Participants Who Complete at Least 50% of Planned Visits
Time frame: 6 months
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.
Feasibility of the Lupus Nephritis Care Pathway as Measured by the Feasibility of Intervention Measure
Time frame: 6 months
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.
Acceptability of the Lupus Nephritis Care Pathway as Measured by the Acceptability of Intervention Measure
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Dana Burshell, MPH contact
Kai Sun, MD, MS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lupus Nephritis (LN) Care Pathway in people with Lupus Nephritis (LN), run by Duke University at 1 site in United States.
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 6 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edna Scarlett (919-684-6150, edna.scarlett@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Eligible Patients Who Consent to and Enroll in the Study (time frame: From study start through completion of enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.