Lupus NephritisENLIGHT-LNNCT05337124
A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US
An observational study of Lupus Nephritis, run by Aurinia Pharmaceuticals Inc. at 1 site in United States.
Trial summary
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- LUPKYNIS
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 31 Jan 2025
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All lupus nephritis patients that meet the eligibility criteria
Who may be able to join
- Lupus nephritis (LN) confirmed by biopsy
- Initiating or have initiated treatment with commercial LUPKYNIS as per US approved Prescribing Information (PI)
- Written informed consent
Who cannot join
- Off-label use (Use of LUPKYNIS outside of the FDA-approved US Prescribing Information)
Trial locations and contacts
1 site in 1 country.
About this study
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).
Read the detailed description
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in patients with lupus nephritis (LN) in the United States (US). This registry is intended to benefit and support interests of patients, clinicians, regulatory bodies, payers, and industry by obtaining longitudinal data on LUPKYNIS.
- Conditions
- Lupus Nephritis
- Being tested
- LUPKYNIS
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUPKYNISDrug
Also called voclosporin
LUPKYNIS treatment per the approved US Prescribing Information
| Study group | Role | What they receive |
|---|---|---|
| Lupkynis Treatment Group | Not described Receives: Drug: LUPKYNIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
LUPKYNIS utilization patterns
The proportion of patients that had their first Urine Protein Creatinine Ratio (UPCR) >0.5 mg within 6 months of initiating LUPKYNIS.
Measured: 12 months (1 year) to 60 months (5 years)
Effectiveness of LUPKYNIS
The proportion of patients that achieve Urine Protein Creatinine Ratio (UPCR) <=0.5 mg after initiating LUPKYNIS by race, ethnicity, and previous LN treatment.
Measured: 12 months (1 year) to 60 months (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start5 Apr 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United BioSource, LLC
- Responsible party
- Sponsor
- Investigators
- Aurinia Study Director, Study director, Aurinia Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337124
- Sponsor's protocol ID
- AUR-VCS-2021-03
- Acronym
- ENLIGHT-LN
- Status last verified
- Jun 2025
- First submitted
- 22 Mar 2022
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US
- ClinicalTrials.gov ID
- NCT05337124
- Acronym / sponsor ID
- ENLIGHT-LN / AUR-VCS-2021-03
- Conditions
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- United BioSource, LLC
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 20 Apr 2022 (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.
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).
Detailed description
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in patients with lupus nephritis (LN) in the United States (US). This registry is intended to benefit and support interests of patients, clinicians, regulatory bodies, payers, and industry by obtaining longitudinal data on LUPKYNIS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lupkynis Treatment Group | – | Drug: LUPKYNIS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All lupus nephritis patients that meet the eligibility criteria
Key inclusion criteria (3 listed)
- Lupus nephritis (LN) confirmed by biopsy
- Initiating or have initiated treatment with commercial LUPKYNIS as per US approved Prescribing Information (PI)
- Written informed consent
Key exclusion criteria (1 listed)
- Off-label use (Use of LUPKYNIS outside of the FDA-approved US Prescribing Information)
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 |
|---|---|---|
| LUPKYNISAlso: voclosporinLUPKYNIS treatment per the approved US Prescribing Information | Drug | Lupkynis Treatment Group |
Primary outcome
LUPKYNIS utilization patterns
Time frame: 12 months (1 year) to 60 months (5 years)
The proportion of patients that had their first Urine Protein Creatinine Ratio (UPCR) >0.5 mg within 6 months of initiating LUPKYNIS.
Effectiveness of LUPKYNIS
Time frame: 12 months (1 year) to 60 months (5 years)
The proportion of patients that achieve Urine Protein Creatinine Ratio (UPCR) <=0.5 mg after initiating LUPKYNIS by race, ethnicity, and previous LN treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Lupus Nephritis
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
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. This study is not recruiting at the moment.
Aurinia Study Director study director
Aurinia Pharmaceuticals Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, run by Aurinia Pharmaceuticals Inc. 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LUPKYNIS utilization patterns (time frame: 12 months (1 year) to 60 months (5 years)). The study lists 2 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 24 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.