|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Columbia University |
|---|---|
| Collaborator: |
Centocor Research & Development, Inc. |
| Information provided by (Responsible Party): | Columbia University |
| ClinicalTrials.gov Identifier: | NCT01470183 |
Purpose
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:
| Condition |
|---|
|
Lupus Nephritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
Lupus Nephritis Patients
|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
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:
Exclusion Criteria:
Contacts and Locations| Contact: Andrew S Bomback, MD | 212-305-3273 | asb68@columbia.edu |
| Contact: Pietro Canetta, MD | 212-305-3273 | pac2004@columbia.edu |
| United States, New York | |
| Columbia University Medical Center, Division of Nephrology, Glomerular Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Andrew S Bomback, MD 212-305-3273 asb68@columbia.edu | |
| Contact: Pietro Canetta, MD 212-305-3273 pac2004@columbia.edu | |
| Principal Investigator: Gerald B Appel, MD | |
| Sub-Investigator: Andrew S Bomback, MD | |
| Sub-Investigator: Pietro Canetta, MD | |
More Information
| Responsible Party: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT01470183 History of Changes |
| Other Study ID Numbers: | AAAI1090 |
| Study First Received: | November 7, 2011 |
| Last Updated: | November 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Lupus Nephritis Nephritis Glomerulonephritis Kidney Diseases Urologic Diseases |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |