Lupus NephritisNCT01470183
Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
An observational study of Lupus Nephritis, run by Columbia University at 1 site in United States.
Trial summary
This is an exploratory study. No formal hypothesis will be tested. The objectives of this study are to follow Lupus Nephritis patients over a period of 12 months to: Establish the baseline biomarker characteristics of patients Determine the variability of biomarker measures over time Correlate biomarkers with disease… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus Nephritis
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Feb 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 50 adult patients, 25 with lupus nephritis 25 control patients who have greater than 1 gram per day proteinuria and non-SLE diagnoses, and who qualify for this study based upon the stated inclusion/exclusion criteria will be recruited from the Glomerular Center at Columbia University Medical Center.
Who may be able to join
- Adults between 18 and 80 years of age, inclusive
- Diagnosis of SLE by ACR criteria and biopsy-proven ISN/RPS Class III or IV lupus glomerulonephritis within 2 years
- Persistently active nephritis defined as proteinuria greater than or equal to 1.0 g/day for 3 months or more, AND at least 1 of the following:
- Hematuria (greater than or equal to 5 RBC/hpf) on 2 or more urinalyses done greater than or equal to 2 weeks apart
- anti-dsDNA positive or anti-Smith positive, or
- low C3 or C4 complement level. (d) Stable immunosuppression consisting of mycophenolate mofetil (MMF) 13 g/day with/without corticosteroids up to prednisone equivalent of 15 mg/day, or azathioprine 13 mg/kg/day with/without corticosteroids up to prednisone equivalent of 20 mg/day.
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- Stable dose of ACE inhibitor/ARB for 4 weeks prior to study enrollment, unless previously intolerant to or having a contraindication to ACE inhibitors and ARBs
- If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 15 mg/day of prednisone for at least 4 weeks prior to study enrollment. If currently not using corticosteroids, the subject must not have received oral corticosteroids for at least 4 weeks prior study enrollment.
- Clarification of inclusion criteria for controls: Any patient with an idiopathic glomerular disease who does not have lupus nephritis. This includes patients with minimal change disease, membranous nephropathy, focal segmental glomerulosclerosis, and IgA nephropathy.
Who cannot join
- B-cell depletion therapy in past 1 yr, or evidence of persistent B cell depletion at the time of screening.
- Received an investigational drug (including vaccines) or used an investigational medical device within 3 months of study enrollment or within 5 half-lives of agent, whichever is longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center, Division of Nephrology, Glomerular Center
New York, New York, 10032
About this study
This is an exploratory study. No formal hypothesis will be tested.
The objectives of this study are to follow Lupus Nephritis patients over a period of 12 months to:
- Establish the baseline biomarker characteristics of patients
- Determine the variability of biomarker measures over time
- Correlate biomarkers with disease phenotype
- Conditions
- Lupus Nephritis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Lupus Nephritis Patients | 1. Male or female subjects age 18 and older 2. Must have confirmed diagnosis of Class III or Class IV lupus nephritis by biopsy 3. Must have stable disease on medication at time of enrollment | |
| Control Patients | Any patient with an idiopathic glomerular disease who does not have lupus nephritis. This includes patients with minimal change disease, membranous nephropathy, focal segmental glomerulosclerosis, and IgA nephropathy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mRNA
Whole blood samples will be collected from all subjects for the analysis of mRNA expression of genes relevant to lupus nephritis (IFNa signature, TNFa/TNFa receptor families, defensins, TH1, TH17 related pathway genes.
Measured: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12
Change in Proteinuria
Urine (12-hour collections) will be obtained from all subjects in the study for the analysis of proteins relevant to lupus nephritis.
Measured: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12
Change in Creatinine
Serum will be collected from all subjects in the study for the analysis of proteins relevant to lupus nephritis.
Measured: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
- Study completionFeb 2013
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.
- More trials run by Columbia 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor Research & Development, Inc.
- Responsible party
- Principal investigator, Gerald B. Appel, Columbia University
- Investigators
- Gerald Appel, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470183
- Sponsor's protocol ID
- AAAI1090
- Status last verified
- Feb 2014
- First submitted
- 7 Nov 2011
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
- ClinicalTrials.gov ID
- NCT01470183
- Acronym / sponsor ID
- AAAI1090
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Centocor Research & Development, Inc.
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Nov 2011 (estimated)
- 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 is an exploratory study. No formal hypothesis will be tested.
The objectives of this study are to follow Lupus Nephritis patients over a period of 12 months to:
- Establish the baseline biomarker characteristics of patients
- Determine the variability of biomarker measures over time
- Correlate biomarkers with disease phenotype
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lupus Nephritis Patients | – | –1. Male or female subjects age 18 and older 2. Must have confirmed diagnosis of Class III or Class IV lupus nephritis by biopsy 3. Must have stable disease on medication at time of enrollment |
| Control Patients | – | –Any patient with an idiopathic glomerular disease who does not have lupus nephritis. This includes patients with minimal change disease, membranous nephropathy, focal segmental glomerulosclerosis, and IgA nephropathy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 50 adult patients, 25 with lupus nephritis 25 control patients who have greater than 1 gram per day proteinuria and non-SLE diagnoses, and who qualify for this study based upon the stated inclusion/exclusion criteria will be recruited from the Glomerular Center at Columbia University Medical Center.
Key inclusion criteria (9 listed)
- Adults between 18 and 80 years of age, inclusive
- Diagnosis of SLE by ACR criteria and biopsy-proven ISN/RPS Class III or IV lupus glomerulonephritis within 2 years
- Persistently active nephritis defined as proteinuria greater than or equal to 1.0 g/day for 3 months or more, AND at least 1 of the following:
- Stable dose of ACE inhibitor/ARB for 4 weeks prior to study enrollment, unless previously intolerant to or having a contraindication to ACE inhibitors and ARBs
- If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 15 mg/day of prednisone for at least 4 weeks prior to study enrollment. If currently not using corticosteroids, the subject must not have received oral corticosteroids for at least 4 weeks prior study enrollment.
Key exclusion criteria (2 listed)
- B-cell depletion therapy in past 1 yr, or evidence of persistent B cell depletion at the time of screening.
- Received an investigational drug (including vaccines) or used an investigational medical device within 3 months of study enrollment or within 5 half-lives of agent, whichever is longer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in mRNA
Time frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12
Whole blood samples will be collected from all subjects for the analysis of mRNA expression of genes relevant to lupus nephritis (IFNa signature, TNFa/TNFa receptor families, defensins, TH1, TH17 related pathway genes.
Change in Proteinuria
Time frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12
Urine (12-hour collections) will be obtained from all subjects in the study for the analysis of proteins relevant to lupus nephritis.
Change in Creatinine
Time frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12
Serum will be collected from all subjects in the study for the analysis of proteins relevant to lupus nephritis.
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 7 Feb 2014.
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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. This study is not recruiting at the moment.
Gerald Appel, MD principal investigator
Columbia University
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 Columbia 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 9 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: finished, as of the sponsor's last update on 7 Feb 2014. 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?
Change in mRNA (time frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12). The study lists 3 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 7 Feb 2014.