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NCT00977977 · ClinicalTrials.gov registry record · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
A Phase 2 study of Autoimmune Disease and Proteinuria, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT00977977 is a Phase 2 study of Autoimmune Disease and Proteinuria that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 30 participants, below the 1,508-participant average among 10 other Autoimmune Disease trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00977977, a Phase 2 study of Autoimmune Disease and Proteinuria, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: * Membranous nephropathy is associated with damage to the walls of the glomeruli, the small blood vessels in the kidneys that filter waste products from the blood. This damage causes leakage of blood proteins into the urine and is associated with low blood protein levels, high blood cholesterol values, and swelling of the legs. These problems can decrease or go away without treatment in about 25 percent of patients, but if they persist, some patients may experience impaired (or loss of) kidney function, blood vessel and heart disease, and a risk of forming blood clots in veins. * Kidney biopsies that show that antibodies have been deposited along the glomeruli suggest that specialized cells of the immune system, called B and T cells, are causing damage to the kidneys through their increased activity. To suppress the action of B and T cells and to decrease the harmful deposits in the kidneys, drug treatments are required. * Patients with membranous nephropathy are often treated with immunosuppressive drugs such as cyclosporine or cytoxan plus steroids that attempt to reduce or suppress the activity of the immune system, decrease antibody production, and reduce antibody deposits in the kidney. However, not everyone responds to these medications and the kidney disease can return in some patients when the drugs are stopped. Also, there are side effects associated with long term usage of these medications. Rituximab, a different immunosuppressant, has also been used for this purpose. Although cyclosporine and Rituximab have been used separately, they have not been tried in combination as a possible treatment for membranous nephropathy. Objectives: \- To determine the safety and effectiveness of combining rituximab and cyclosporine to treat membranous nephropathy. Eligibility: \- Individuals 18 years of age and older who have been diagnosed with membranous nephropathy based on a kidney biopsy done within the preceding 24 months, and who have had excess le
Conditions Studied
Interventions
- DRUG Rituximab Infusion
- DRUG Oral Cyclosporine
Study Locations (2)
Maryland
- National Naval Medical Center - Bethesda
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-12-22 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00977977
The ClinicalTrials.gov registry entry for NCT00977977 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,508-participant average among 10 other Autoimmune Disease trials with a reported enrollment target (98% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Autoimmune Disease appearing as the primary indexed condition, and to 2 interventions - of which Rituximab Infusion is the first listed.
NCT00977977 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00977977 about?
NCT00977977 is a clinical study titled "Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy". Background: * Membranous nephropathy is associated with damage to the walls of the glomeruli, the small blood vessels in the kidneys that filter waste products from the blood. This damage causes leakage of blood proteins into the urine and is associated with low blood protein levels, high blood cho...
What is the current status of trial NCT00977977?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2010-12-22. Estimated completion is 2027-12-31.
What conditions does trial NCT00977977 study?
This clinical trial studies the following conditions: Autoimmune Disease, Proteinuria, Nephrotic Syndrome, Glomerular Disease, Membranous Glomerulonephritis.
What interventions are being tested in trial NCT00977977?
The interventions under investigation include: Rituximab Infusion (DRUG), Oral Cyclosporine (DRUG).
Who is sponsoring clinical trial NCT00977977?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00977977 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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